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FDA 510(k)

GALIX MA-6C HOLTER CASSETTE RECORDER

K-Number: K904177 · 1991-09-20

ApplicantGalix Instrumentacion Biomedica
Decision Date1991-09-20
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GALIX MA-6C HOLTER CASSETTE RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Galix Instrumentacion Biomedica. It received FDA 510(k) clearance on 1991-09-20 under 510(k) number K904177. 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 GALIX MA-6C HOLTER CASSETTE RECORDER?

GALIX MA-6C HOLTER CASSETTE RECORDER is a medical device that received FDA 510(k) clearance on 1991-09-20. The listed applicant is Galix Instrumentacion Biomedica. The 510(k) number is K904177.

When did GALIX MA-6C HOLTER CASSETTE RECORDER receive FDA 510(k) clearance?

GALIX MA-6C HOLTER CASSETTE RECORDER received FDA 510(k) clearance on 1991-09-20, under 510(k) number K904177.

Who is the listed applicant for GALIX MA-6C HOLTER CASSETTE RECORDER?

The FDA 510(k) record lists Galix Instrumentacion Biomedica as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GALIX MA-6C HOLTER CASSETTE RECORDER?

The FDA product code for GALIX MA-6C HOLTER CASSETTE RECORDER is DSH.

Related Clinical Trials

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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Other records listing Galix Instrumentacion Biomedica 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.

K904176GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER

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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