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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Powered (Resuscitator)
510(k) Number K851337
Device Name 502 RESUSCITATORY INHALATOR VALVE
Applicant
Life Support Products, Inc.
1340 N. Jefferson
P.O. Box 6146
Anaheim,  CA  92806
Applicant Contact DONALD C FABISH
Correspondent
Life Support Products, Inc.
1340 N. Jefferson
P.O. Box 6146
Anaheim,  CA  92806
Correspondent Contact DONALD C FABISH
Regulation Number868.5925
Classification Product Code
BTL  
Date Received04/03/1985
Decision Date 05/15/1985
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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