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FDA 510(k)

RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100

K-Number: K032882 · 2004-01-28

ApplicantRecom Managed Systems, Inc.
Decision Date2004-01-28
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100 is the device name listed in this FDA 510(k) record. The listed applicant is Recom Managed Systems, Inc.. It received FDA 510(k) clearance on 2004-01-28 under 510(k) number K032882. 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 RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100?

RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100 is a medical device that received FDA 510(k) clearance on 2004-01-28. The listed applicant is Recom Managed Systems, Inc.. The 510(k) number is K032882.

When did RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100 receive FDA 510(k) clearance?

RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100 received FDA 510(k) clearance on 2004-01-28, under 510(k) number K032882.

Who is the listed applicant for RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100?

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

What is the FDA product code for RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100?

The FDA product code for RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100 is MWJ.

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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

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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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