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FDA 510(k)

ENGUARD REMOTE PATIENT MONITOR

K-Number: K020632 · 2002-03-15

ApplicantMennen Medical , Ltd.
Decision Date2002-03-15
Product CodeQYX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENGUARD REMOTE PATIENT MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Mennen Medical , Ltd.. It received FDA 510(k) clearance on 2002-03-15 under 510(k) number K020632. The device is classified under product code QYX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENGUARD REMOTE PATIENT MONITOR?

ENGUARD REMOTE PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 2002-03-15. The listed applicant is Mennen Medical , Ltd.. The 510(k) number is K020632.

When did ENGUARD REMOTE PATIENT MONITOR receive FDA 510(k) clearance?

ENGUARD REMOTE PATIENT MONITOR received FDA 510(k) clearance on 2002-03-15, under 510(k) number K020632.

Who is the listed applicant for ENGUARD REMOTE PATIENT MONITOR?

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

What is the FDA product code for ENGUARD REMOTE PATIENT MONITOR?

The FDA product code for ENGUARD REMOTE PATIENT MONITOR is QYX.

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Other records listing Mennen Medical , Ltd. 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.

K131789CEREBRALOGIK- AEEGK123792HORIZON XVU (FFR)K093766VITALOGIK 6000/6500K091165HORIZON XVUK083063BIS INTERFACE FOR VITALOGIK PATIENT MONITORSK081484HORIZON XVU

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Related Devices (Code: QYX)

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.

K250793RhythmStar System (SL)RhythMedix, LLCK241179Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc.K240653SmartCardia 7L Platform (MCT)Smartcardia SAK240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.K233584RhythmStar SystemRhythMedix, LLCK162956NOWCARDIO SYSTEMContex International Technologies (Canada), 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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