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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K832467
Device Name PORTABLE LIFECARE VENTILATOR PLV-100
Applicant
LIFECARE SERVICES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
LIFECARE SERVICES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/02/1983
Decision Date 10/20/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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