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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 K913423
Device Name LIFECARE REMOTE ALARM II
Applicant
Lifecare Services, Inc.
655 Aspen Ridge Dr.
Lafayette,  CO  80026
Applicant Contact HAROLD R ELLERINGTO
Correspondent
Lifecare Services, Inc.
655 Aspen Ridge Dr.
Lafayette,  CO  80026
Correspondent Contact HAROLD R ELLERINGTO
Regulation Number868.5895
Classification Product Code
CBK  
Date Received07/22/1991
Decision Date 01/30/1992
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
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