PORTABLE LIFECARE VENTILATOR PLV-100

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 Portable Lifecare Ventilator Plv-100.

Pre-market Notification Details

Device IDK832467
510k NumberK832467
Device Name:PORTABLE LIFECARE VENTILATOR PLV-100
ClassificationVentilator, Continuous, Facility Use
Applicant LIFECARE SERVICES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-08-02
Decision Date1983-10-20

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