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FDA 510(k)

CLICK HOLTER

K-Number: K032276 · 2003-08-27

ApplicantRemco Italia S.P.A.
Decision Date2003-08-27
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CLICK HOLTER is the device name listed in this FDA 510(k) record. The listed applicant is Remco Italia S.P.A.. It received FDA 510(k) clearance on 2003-08-27 under 510(k) number K032276. 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 CLICK HOLTER?

CLICK HOLTER is a medical device that received FDA 510(k) clearance on 2003-08-27. The listed applicant is Remco Italia S.P.A.. The 510(k) number is K032276.

When did CLICK HOLTER receive FDA 510(k) clearance?

CLICK HOLTER received FDA 510(k) clearance on 2003-08-27, under 510(k) number K032276.

Who is the listed applicant for CLICK HOLTER?

The FDA 510(k) record lists Remco Italia S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLICK HOLTER?

The FDA product code for CLICK HOLTER is MWJ.

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Other records listing Remco Italia S.P.A. 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.

K032200ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPHK852770CARIOLINE(ELECTROCARDIOGRAPH)

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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