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FDA 510(k)

DIGITAL AMBULATORY ECG (HOLTER) RECORDER

K-Number: K031074 · 2003-10-15

ApplicantDatrix
Decision Date2003-10-15
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIGITAL AMBULATORY ECG (HOLTER) RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Datrix. It received FDA 510(k) clearance on 2003-10-15 under 510(k) number K031074. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL AMBULATORY ECG (HOLTER) RECORDER?

DIGITAL AMBULATORY ECG (HOLTER) RECORDER is a medical device that received FDA 510(k) clearance on 2003-10-15. The listed applicant is Datrix. The 510(k) number is K031074.

When did DIGITAL AMBULATORY ECG (HOLTER) RECORDER receive FDA 510(k) clearance?

DIGITAL AMBULATORY ECG (HOLTER) RECORDER received FDA 510(k) clearance on 2003-10-15, under 510(k) number K031074.

Who is the listed applicant for DIGITAL AMBULATORY ECG (HOLTER) RECORDER?

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 DIGITAL AMBULATORY ECG (HOLTER) RECORDER?

The FDA product code for DIGITAL AMBULATORY ECG (HOLTER) RECORDER is MWJ.

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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 ELECTROCARDIOGRAPHK052883CARDIOSERVERK982975DIGITAL ECG HOLTER RECORDER, MODEL DR512K921068GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300

Related Devices (Code: MWJ)

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.

K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303)Shenzhen Xinyan Medical Technology Co.,ltd.K253529Peerbridge COR MDx (Cor MDx)Peerbridge Health, Inc.K253562medilogFDSchiller AGK253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)Seers Technology Co., Ltd.K252839ZywieZ3 Sensor & AdhesiveZywie, Inc.K231424HeartBeam AIMIGo(TM) SystemHeartbeam, Inc.

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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