ENVOY PATIENT MONITOR

Detector And Alarm, Arrhythmia

MENNEN MEDICAL, INC.

The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Envoy Patient Monitor.

Pre-market Notification Details

Device IDK974510
510k NumberK974510
Device Name:ENVOY PATIENT MONITOR
ClassificationDetector And Alarm, Arrhythmia
Applicant MENNEN MEDICAL, INC. KIRYAT WEIZMANN SCIENCE PARK P.O. BOX 102 Rehovot,  IL 76100
ContactKenneth Raichman
CorrespondentKenneth Raichman
MENNEN MEDICAL, INC. KIRYAT WEIZMANN SCIENCE PARK P.O. BOX 102 Rehovot,  IL 76100
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-12-01
Decision Date1998-04-14
Summary:summary

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