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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 K862212
Device Name LIFECARE REMOTE ALARM #34-001
Applicant
LIFECARE SERVICES, INC.
5505 CENTRAL AVE.
BOULDER,  CO  80301
Applicant Contact MARC BERGMAN
Correspondent
LIFECARE SERVICES, INC.
5505 CENTRAL AVE.
BOULDER,  CO  80301
Correspondent Contact MARC BERGMAN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/10/1986
Decision Date 06/23/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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