LIFECARE REMOTE ALARM II

Ventilator, Continuous, Facility Use

LIFECARE SERVICES, INC.

The following data is part of a premarket notification filed by Lifecare Services, Inc. with the FDA for Lifecare Remote Alarm Ii.

Pre-market Notification Details

Device IDK913423
510k NumberK913423
Device Name:LIFECARE REMOTE ALARM II
ClassificationVentilator, Continuous, Facility Use
Applicant LIFECARE SERVICES, INC. 655 ASPEN RIDGE DR. Lafayette,  CO  80026
ContactHarold R Elleringto
CorrespondentHarold R Elleringto
LIFECARE SERVICES, INC. 655 ASPEN RIDGE DR. Lafayette,  CO  80026
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-22
Decision Date1992-01-30

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