Omron Electronics, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Omron Electronics, Inc. makes
Omron Electronics, Inc. manufactures digital blood pressure monitors, including models such as the HEM-814F, HEM-401C, HEM-701C, and HEM-703CP, designed for home and clinical use. The company also produces digital fever thermometers, including the MC-7, MC-3, MC-12B, and MC-5, intended for oral, tympanic, and other temperature measurements. Additionally, it offers a travel massager (HM-01) and a pulse stimulator (HV-F05) for muscle relaxation and therapeutic purposes.
These devices are classified under FDA regulations as Class I and Class II, with relevant submissions recorded in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Omron Digital Fever Thermometer Model Mc-7 Ref K870956
Regimes: 510(k) Registry: 510(k)Omron Digital Fever Thermometer Model Mc-3 Ref K881415
Regimes: 510(k) Registry: 510(k)Omron Digital Fever Thermometer Model Mc-12B Ref K872527
Regimes: 510(k) Registry: 510(k)Omron Digital Blood Pressure Monitor Hem-401C Ref K871207
Regimes: 510(k) Registry: 510(k)Omron Travel Massager, Model Hm-01 Ref K893029
Regimes: 510(k) Registry: 510(k)Omron Digital Blood Pressure Monitor Hem-701C Ref K881269
Regimes: 510(k) Registry: 510(k)Digital Fever Thermometer Model Mc-5 Ref K871888
Regimes: 510(k) Registry: 510(k)Digital Blood Pressure Monitor Model Hem-703CP Ref K882393
Regimes: 510(k) Registry: 510(k)Omron Pulse Stimulator Model Hv-F05 Ref K902255
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Omron Electronics, Inc. have in the registry?
The registry currently lists 10 devices for Omron Electronics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Omron Electronics, Inc.'s devices?
Among its 10 most recently registered devices, Omron Electronics, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Omron Electronics, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Omron Electronics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Omron Electronics, Inc. in the registry?
The most recently registered devices listed for Omron Electronics, Inc. include OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM814F, OMRON DIGITAL FEVER THERMOMETER MODEL MC-7, OMRON DIGITAL FEVER THERMOMETER MODEL MC-3 and OMRON DIGITAL FEVER THERMOMETER MODEL MC-12B.