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FDA 510(k)

RHYTHMSCAN HR HOLTER RECORDER

K-Number: K882366 · 1988-08-02

ApplicantBrentwood Instruments, Inc.
Decision Date1988-08-02
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RHYTHMSCAN HR HOLTER RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Brentwood Instruments, Inc.. It received FDA 510(k) clearance on 1988-08-02 under 510(k) number K882366. 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 RHYTHMSCAN HR HOLTER RECORDER?

RHYTHMSCAN HR HOLTER RECORDER is a medical device that received FDA 510(k) clearance on 1988-08-02. The listed applicant is Brentwood Instruments, Inc.. The 510(k) number is K882366.

When did RHYTHMSCAN HR HOLTER RECORDER receive FDA 510(k) clearance?

RHYTHMSCAN HR HOLTER RECORDER received FDA 510(k) clearance on 1988-08-02, under 510(k) number K882366.

Who is the listed applicant for RHYTHMSCAN HR HOLTER RECORDER?

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

What is the FDA product code for RHYTHMSCAN HR HOLTER RECORDER?

The FDA product code for RHYTHMSCAN HR HOLTER RECORDER is DSH.

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Other records listing Brentwood Instruments, 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.

K896924SPIROSCAN 4000K871572RHYTHMSCANK860024FUKUDA DENSHI CARDIMAX FCP-211K853979CARDIMAX FX-1164K854505CARDIMAX FX-406UK851135SPIRO SCAN

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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

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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