LIFECARE CPAP-100

Ventilator, Non-continuous (respirator)

LIFECARE SERVICES, INC.

The following data is part of a premarket notification filed by Lifecare Services, Inc. with the FDA for Lifecare Cpap-100.

Pre-market Notification Details

Device IDK912224
510k NumberK912224
Device Name:LIFECARE CPAP-100
ClassificationVentilator, Non-continuous (respirator)
Applicant LIFECARE SERVICES, INC. 655 ASPEN RIDGE DR. Lafayette,  CO  80026
ContactHarold R.ellerington
CorrespondentHarold R.ellerington
LIFECARE SERVICES, INC. 655 ASPEN RIDGE DR. Lafayette,  CO  80026
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-20
Decision Date1991-09-23

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