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NIHON KOHDEN AMERICA, INC.

Last updated September 17, 2026

Information

Country: US
Address: 15353 Barranca Pkwy, Irvine, CA, 92618
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2080783
DUNS Number: —

Catalogue (255)

Page 5 of 6

Device	Model / Reference	Registries	Class	Status
Model Meb-5304 Evoked Potential & Electro. Record	K881177	FDA 510(k)	Class II	Active
Ae-800pa Eeg Module	K884537	FDA 510(k)	Class II	Active
Neuropack 8, Mee-4108	K851300	FDA 510(k)	Class II	Active
Cardiolife Tec-7300 W/Optional Accessories	K880575	FDA 510(k)	Class II	Active
Eeg 42/2p Electro Encephalograph	K831324	FDA 510(k)	Class II	Active
Bsm-2300 &bsm6000 With Cgs-9001 Series Communication Gateway, Model Cgs-9001 Series Optional Accessory	K083271	FDA 510(k)	Class II	Active
Model Ao-800pa Co2 Module	K894691	FDA 510(k)	Class II	Active
Anesthesia Monitor; Bedside Monitor, Series Bsm-5130a	K030105	FDA 510(k)	Class II	Active
Neuropack 8 Mee 4108	K841497	FDA 510(k)	Class II	Active
Cosmos	K823220	FDA 510(k)	Class II	Active
Electrocardiograph, Model Ecg-5503	K801677	FDA 510(k)	Class II	Active
Nihon Kohden Qp-160ak Eeg Trend Program	K092573	FDA 510(k)	Class II	Active
Tec-3500 Defibrillator	K840258	FDA 510(k)	Class II	Active
Nihon Kohden Ecg-9320a Cardiofax And Accessories	K961272	FDA 510(k)	N/A	Active
Mem-7102; Meb-7102 Evoked Response & Electro Recor	K890274	FDA 510(k)	Class II	Active
Cardiofax-V Ecg-834oa	K865032	FDA 510(k)	Class II	Active
Cardiofax Ce, Model Pea-1110k	K042827	FDA 510(k)	Class II	Active
Lifescope 6 Oec-6105	K841502	FDA 510(k)	Class II	Active
Cardiolife Tec 7100	K863404	FDA 510(k)	Class II	Active
Lifescope Ii	K841499	FDA 510(k)	Class II	Active
Stimulator Model Sss-1101	K791149	FDA 510(k)	Class II	Active
Long Term Recorder Rag 1200	K854866	FDA 510(k)	Class I	Active
Ap-860pa Nibp Module	K910629	FDA 510(k)	Class II	Active
Nihon Kohden Bedside Monitor, Model Bsm-6000s Series	K080342	FDA 510(k)	Class II	Active
Yg-125t And Yg-135t Nasal Adapter	K072843	FDA 510(k)	Class II	Active
Lifescope 6 Oec-6102	K841501	FDA 510(k)	Class II	Active
Eeg-1100a Switch Box	K073491	FDA 510(k)	Class II	Active
Nihon Kohden Electrocardiograph	K813266	FDA 510(k)	Class II	Active
Mee-1000a Neuromaster	K051178	FDA 510(k)	Class II	Active
Multigas Unit, Model Ag-920ra	K020046	FDA 510(k)	Class II	Active
Cardiofax Ecg-6353	K860212	FDA 510(k)	Class II	Active
Nihon Kohden Blood Flowmeters #mfv-1100	K820742	FDA 510(k)	Class II	Active
Prefense Edns-9000 Series Nurse Central Station	K073550	FDA 510(k)	Class II	Active
Transmitter, Zs-940pa Series	K043517	FDA 510(k)	Class II	Active
Ambulatory Eeg/Sleep Recorder And Accessories, Model # Ssr3201	K983072	FDA 510(k)	Class II	Active
Ws 800r Thermal Array Recorder	K881831	FDA 510(k)	Class I	Active
Nihon Kohden Neuropack Sigma Meb-5500a Evoked Response & Emg Measuring System	K950208	FDA 510(k)	Class II	Active
Multiple Patient Receiver, Model Org-9700a	K071058	FDA 510(k)	Class II	Active
Electroencephalograph Ecg-6151	K820067	FDA 510(k)	Class II	Active
Wireless Input Unit, Model Wee-1000a Series	K033475	FDA 510(k)	Class II	Active
Nihon Kohden Tec-6100a Cardiolife Mini Defibrillator & Accessories	K971194	FDA 510(k)	Class II	Active
Nihon Kohden Eeg-1200a With Je-120a Multi Channel Electrode Junction Box	K113117	FDA 510(k)	Class II	Active
Cns-9700 Series Central Nurse Station And Accessories	K023475	FDA 510(k)	Class II	Active
Nihon Kohden Central Nurse Station, Cns-8310a/Cns-8350a	K935877	FDA 510(k)	Class II	Active
Life Scope Ec, Model Bsm-1102	K000517	FDA 510(k)	Class II	Active
Nihon Kohden Bsm-2300a Series Bedside Monitor And Accessories, Model Bsm-2300a Series	K011918	FDA 510(k)	Class II	Active
Tec-8251a Defibrillator Monitor, Modification	K914971	FDA 510(k)	Class II	Active
Cardiofax Ce, Model Ecg-1500 A	K052511	FDA 510(k)	Class II	Active
Nihon Kohden Qp-160 Ak Trend Program With The Addition Of Dsa Asymmetry Trend And Fft P	K120485	FDA 510(k)	Class II	Active
Lifescope 6, Oec-6120 Portable Patient Monitor Rec	K862462	FDA 510(k)	Class II	Active

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FDA Recalls (12)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 18, 2024	Z-0267-2025	—	open, classified	Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Sep 18, 2024	Z-0268-2025	—	open, classified	Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Apr 29, 2024	Z-2025-2024	—	open, classified	Due to software issue the device may give false "SpO2 Probe Failure" alarm
Apr 29, 2022	Z-0314-2025	—	open, classified	Due to products being shipped/distributed to customers after the products expiration date had past.
Jan 8, 2021	Z-1162-2021	—	open, classified	Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.
Dec 21, 2020	Z-0865-2021	—	open, classified	Medical device non-conformance to electrical safety standard (IEC 60601-1).
Mar 13, 2017	Z-1768-2017	—	terminated	The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
Apr 14, 2015	Z-1543-2015	—	terminated	Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound.
Jun 3, 2014	Z-1979-2014	—	terminated	Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting in a period of approximately 3 minutes during which time the system does not display patient data and does not emit alarms based on that data should they be appropriate.
Jan 19, 2012	Z-0817-2016	—	terminated	The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Gas arrestors on these boards which were intended to provide protection from electrostatic discharge failed to prohibit unintentional current flow.
Aug 23, 2006	Z-0218-2007	—	terminated	When the device is subject to physical shock, such as a drop to the floor, it may output a different value from the preset value. This may result in a superficial burn on the patient if the stimulation is done for a long time.
Dec 5, 2003	Z-0506-04	—	terminated	Manufacturing error results in screw affecting electromagnetic interferences. Also metal lid is not tight enough.