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FDA 510(k)

CARDIOMEM CM 3000-12BT

K-Number: K063042 · 2007-05-30

ApplicantGetemed Medizin- Und Informationstechnik AG
Decision Date2007-05-30
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOMEM CM 3000-12BT is the device name listed in this FDA 510(k) record. The listed applicant is Getemed Medizin- Und Informationstechnik AG. It received FDA 510(k) clearance on 2007-05-30 under 510(k) number K063042. 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 CARDIOMEM CM 3000-12BT?

CARDIOMEM CM 3000-12BT is a medical device that received FDA 510(k) clearance on 2007-05-30. The listed applicant is Getemed Medizin- Und Informationstechnik AG. The 510(k) number is K063042.

When did CARDIOMEM CM 3000-12BT receive FDA 510(k) clearance?

CARDIOMEM CM 3000-12BT received FDA 510(k) clearance on 2007-05-30, under 510(k) number K063042.

Who is the listed applicant for CARDIOMEM CM 3000-12BT?

The FDA 510(k) record lists Getemed Medizin- Und Informationstechnik AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOMEM CM 3000-12BT?

The FDA product code for CARDIOMEM CM 3000-12BT is MWJ.

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Other records listing Getemed Medizin- Und Informationstechnik AG 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.

K162023CardioDay V2.5K130516CARDIODAYK130785SEER 1000K122272CARDIOMEMK070280CARDIODAY, VERSION 2.0K051686CARDIOMEM CM 3000-12

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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