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FDA 510(k)

HOLTER RECORDER H3+

K-Number: K043010 · 2005-02-25

ApplicantMortara Instrument, Inc.
Decision Date2005-02-25
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOLTER RECORDER H3+ is the device name listed in this FDA 510(k) record. The listed applicant is Mortara Instrument, Inc.. It received FDA 510(k) clearance on 2005-02-25 under 510(k) number K043010. 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 HOLTER RECORDER H3+?

HOLTER RECORDER H3+ is a medical device that received FDA 510(k) clearance on 2005-02-25. The listed applicant is Mortara Instrument, Inc.. The 510(k) number is K043010.

When did HOLTER RECORDER H3+ receive FDA 510(k) clearance?

HOLTER RECORDER H3+ received FDA 510(k) clearance on 2005-02-25, under 510(k) number K043010.

Who is the listed applicant for HOLTER RECORDER H3+?

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

What is the FDA product code for HOLTER RECORDER H3+?

The FDA product code for HOLTER RECORDER H3+ is MWJ.

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Other records listing Mortara Instrument, Inc. as applicant

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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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