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FDA 510(k)

MODIFICATION TO ENVOY PATIENT MONITOR

K-Number: K023798 · 2002-12-03

ApplicantMennen Medical , Ltd.
Decision Date2002-12-03
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ENVOY 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 2002-12-03 under 510(k) number K023798. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO ENVOY PATIENT MONITOR?

MODIFICATION TO ENVOY PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 2002-12-03. The listed applicant is Mennen Medical , Ltd.. The 510(k) number is K023798.

When did MODIFICATION TO ENVOY PATIENT MONITOR receive FDA 510(k) clearance?

MODIFICATION TO ENVOY PATIENT MONITOR received FDA 510(k) clearance on 2002-12-03, under 510(k) number K023798.

Who is the listed applicant for MODIFICATION TO ENVOY 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 MODIFICATION TO ENVOY PATIENT MONITOR?

The FDA product code for MODIFICATION TO ENVOY PATIENT MONITOR is DSI.

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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: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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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