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FDA 510(k)

NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100

K-Number: K993643 · 1999-12-28

ApplicantNexan Telemed , Ltd.
Decision Date1999-12-28
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100 is the device name listed in this FDA 510(k) record. The listed applicant is Nexan Telemed , Ltd.. It received FDA 510(k) clearance on 1999-12-28 under 510(k) number K993643. 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 NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100?

NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100 is a medical device that received FDA 510(k) clearance on 1999-12-28. The listed applicant is Nexan Telemed , Ltd.. The 510(k) number is K993643.

When did NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100 receive FDA 510(k) clearance?

NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100 received FDA 510(k) clearance on 1999-12-28, under 510(k) number K993643.

Who is the listed applicant for NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100?

The FDA 510(k) record lists Nexan Telemed , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100?

The FDA product code for NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 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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