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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K851135
Device Name SPIRO SCAN
Applicant
Brentwood Instruments, Inc.
2909 Oregon Court
Torrance,  CA  90503
Applicant Contact JAMES OBERMAYER
Correspondent
Brentwood Instruments, Inc.
2909 Oregon Court
Torrance,  CA  90503
Correspondent Contact JAMES OBERMAYER
Regulation Number868.1840
Classification Product Code
BZG  
Date Received03/21/1985
Decision Date 07/01/1985
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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