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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Air, Portable
510(k) Number K853944
Device Name CPAP BLOWER
Applicant
American Air & Process, Inc.
1031 E. Battlefield
Springfield,  MO  65807
Applicant Contact ROBERT C HANSEN
Correspondent
American Air & Process, Inc.
1031 E. Battlefield
Springfield,  MO  65807
Correspondent Contact ROBERT C HANSEN
Regulation Number868.6250
Classification Product Code
BTI  
Date Received09/24/1985
Decision Date 11/21/1985
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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