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FDA 510(k)

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

K-Number: K904176 · 1991-09-20

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

Device Summary

GALIX MODEL MA-6R HOLTER REEL-TO-REEL 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 K904176. 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 MODEL MA-6R HOLTER REEL-TO-REEL RECORDER?

GALIX MODEL MA-6R HOLTER REEL-TO-REEL 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 K904176.

When did GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER receive FDA 510(k) clearance?

GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER received FDA 510(k) clearance on 1991-09-20, under 510(k) number K904176.

Who is the listed applicant for GALIX MODEL MA-6R HOLTER REEL-TO-REEL 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 MODEL MA-6R HOLTER REEL-TO-REEL RECORDER?

The FDA product code for GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER is DSH.

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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.

K904177GALIX MA-6C HOLTER CASSETTE 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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