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FDA 510(k)

CARDIORHYTHM 2000

K-Number: K841472 · 1984-10-29

ApplicantBiogenix, Inc.
Decision Date1984-10-29
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIORHYTHM 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Biogenix, Inc.. It received FDA 510(k) clearance on 1984-10-29 under 510(k) number K841472. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIORHYTHM 2000?

CARDIORHYTHM 2000 is a medical device that received FDA 510(k) clearance on 1984-10-29. The listed applicant is Biogenix, Inc.. The 510(k) number is K841472.

When did CARDIORHYTHM 2000 receive FDA 510(k) clearance?

CARDIORHYTHM 2000 received FDA 510(k) clearance on 1984-10-29, under 510(k) number K841472.

Who is the listed applicant for CARDIORHYTHM 2000?

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

What is the FDA product code for CARDIORHYTHM 2000?

The FDA product code for CARDIORHYTHM 2000 is DSH.

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Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

Official Source

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

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