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FDA 510(k)

INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER

K-Number: K112601 · 2011-11-09

ApplicantIntricon Datrix Corporation
Decision Date2011-11-09
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Intricon Datrix Corporation. It received FDA 510(k) clearance on 2011-11-09 under 510(k) number K112601. 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 INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER?

INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER is a medical device that received FDA 510(k) clearance on 2011-11-09. The listed applicant is Intricon Datrix Corporation. The 510(k) number is K112601.

When did INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER receive FDA 510(k) clearance?

INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER received FDA 510(k) clearance on 2011-11-09, under 510(k) number K112601.

Who is the listed applicant for INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER?

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

What is the FDA product code for INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER?

The FDA product code for INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER is MWJ.

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Other records listing Intricon Datrix Corporation 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.

K111160INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS)

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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