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FDA 510(k)

HOLTER SSR DIGICORDER(TM)

K-Number: K942653 · 1995-05-10

ApplicantDel Mar Avionics
Decision Date1995-05-10
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOLTER SSR DIGICORDER(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Del Mar Avionics. It received FDA 510(k) clearance on 1995-05-10 under 510(k) number K942653. 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 HOLTER SSR DIGICORDER(TM)?

HOLTER SSR DIGICORDER(TM) is a medical device that received FDA 510(k) clearance on 1995-05-10. The listed applicant is Del Mar Avionics. The 510(k) number is K942653.

When did HOLTER SSR DIGICORDER(TM) receive FDA 510(k) clearance?

HOLTER SSR DIGICORDER(TM) received FDA 510(k) clearance on 1995-05-10, under 510(k) number K942653.

Who is the listed applicant for HOLTER SSR DIGICORDER(TM)?

The FDA 510(k) record lists Del Mar Avionics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOLTER SSR DIGICORDER(TM)?

The FDA product code for HOLTER SSR DIGICORDER(TM) is DSH.

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Other records listing Del Mar Avionics 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.

K990027OMNICORDER, MODEL 464K971696SENTINEL RECORDER, MODELS 471/472K963174HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)K950020HOLTER PACERCORDER(R)K922221SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEMK896862MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM

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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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