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FDA 510(k)

GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300

K-Number: K921068 · 1992-03-30

ApplicantDatrix
Decision Date1992-03-30
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300 is the device name listed in this FDA 510(k) record. The listed applicant is Datrix. It received FDA 510(k) clearance on 1992-03-30 under 510(k) number K921068. 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 GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300?

GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300 is a medical device that received FDA 510(k) clearance on 1992-03-30. The listed applicant is Datrix. The 510(k) number is K921068.

When did GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300 receive FDA 510(k) clearance?

GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300 received FDA 510(k) clearance on 1992-03-30, under 510(k) number K921068.

Who is the listed applicant for GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300?

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

What is the FDA product code for GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300?

The FDA product code for GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300 is DSH.

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Other records listing Datrix 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.

K053083DATRIX CARDIO WIFI ELECTROCARDIOGRAPHK052883CARDIOSERVERK031074DIGITAL AMBULATORY ECG (HOLTER) RECORDERK982975DIGITAL ECG HOLTER RECORDER, MODEL DR512

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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