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FDA 510(k)

NIHON KOHDEN HEART MONITORS OMP 7101-02

K-Number: K813444 · 1981-12-29

ApplicantNihon Kohden America, Inc.
Decision Date1981-12-29
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NIHON KOHDEN HEART MONITORS OMP 7101-02 is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 1981-12-29 under 510(k) number K813444. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIHON KOHDEN HEART MONITORS OMP 7101-02?

NIHON KOHDEN HEART MONITORS OMP 7101-02 is a medical device that received FDA 510(k) clearance on 1981-12-29. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K813444.

When did NIHON KOHDEN HEART MONITORS OMP 7101-02 receive FDA 510(k) clearance?

NIHON KOHDEN HEART MONITORS OMP 7101-02 received FDA 510(k) clearance on 1981-12-29, under 510(k) number K813444.

Who is the listed applicant for NIHON KOHDEN HEART MONITORS OMP 7101-02?

The FDA 510(k) record lists Nihon Kohden America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIHON KOHDEN HEART MONITORS OMP 7101-02?

The FDA product code for NIHON KOHDEN HEART MONITORS OMP 7101-02 is DRT.

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Other records listing Nihon Kohden America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DRT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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