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Nihon Kohden BSM-1101 and BSM-1102 Patient Monitor and Accessories

FDA 510(k)

Class II (US FDA 510(k))

510(k) K973918

by Nihon Kohden America, Inc.

Identifiers

510(k) Number
K973918 FDA 510(k)
FDA Product Code
DRT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2300 FDA 510(k)
Regulation Number
870.2300 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a cardiac monitor, including cardiotachometer and rate alarm functions, intended for measuring heart rate from an electrocardiograph signal. It is classified as a Class II medical device under FDA regulation 870.2300.

The device received traditional 510(k) clearance (K973918) on January 13, 1998, and is manufactured by Nihon Kohden America, Inc. It is supplied as a patient monitoring system with associated accessories for use in clinical settings.

Frequently asked questions

What is the NIHON KOHDEN BSM-1101 and BSM-1102 patient monitor used for?

This device is intended for measuring heart rate from an electrocardiograph signal, including cardiotachometer and rate alarm functions, to support cardiac monitoring in clinical settings.

How is the NIHON KOHDEN BSM-1101 and BSM-1102 supplied and what does it include?

It is supplied as a patient monitoring system with associated accessories for use in clinical environments, designed to work with ECG inputs to provide continuous heart rate monitoring and alerts.

What regulatory pathway was used for the NIHON KOHDEN BSM-1101 and BSM-1102 patient monitor?

The device received traditional 510(k) clearance (K973918) from the FDA on January 13, 1998, based on a determination of substantial equivalence to a legally marketed predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Nihon Kohden Bsm-1101 and Bsm-1102 Patient Monitor and Accessories, Nihon Kohden Bsm-1101 And Bsm-1102 Patient Monitor And Accessories 510 ..., Nihon-Kohden BSM-1101-1102 Bedside Monitor - Service Manual, Nihon-Kohden BSM-1101, BSM-1102 Service manual, Nihon Kohden BSM 1101 1102 Service manual - Archive.org

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nihon Kohden America, Inc.

Sources (1)

  • FDA 510(k) K973918 24 fields · synced Oct 6, 2026