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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, Manual (Resuscitator)
510(k) Number K864125
Device Name CPREVIVER
Applicant
Augerscope, Inc.
12860 Am Fernando Rd.
Sylmar,  CA  91342
Applicant Contact HOWARD G BENTLEY
Correspondent
Augerscope, Inc.
12860 Am Fernando Rd.
Sylmar,  CA  91342
Correspondent Contact HOWARD G BENTLEY
Regulation Number868.5915
Classification Product Code
BTM  
Date Received10/21/1986
Decision Date 02/26/1987
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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