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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K952429
Device Name RES CARE AUTO SET CLINICAL, PORTABLE SYSTEM, PORTABLE 2 SYSTEM
Applicant
RESCARE LTD.
3377 NORTH TORREY PINES COURT
SUITE 300
LA JOLLA,  CA  92037
Applicant Contact ALAN DONALD
Correspondent
RESCARE LTD.
3377 NORTH TORREY PINES COURT
SUITE 300
LA JOLLA,  CA  92037
Correspondent Contact ALAN DONALD
Regulation Number868.5905
Classification Product Code
BZD  
Date Received05/24/1995
Decision Date 07/02/1996
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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