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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 K896924
Device Name SPIROSCAN 4000
Applicant
Brentwood Instruments, Inc.
3425 Lomita Blvd.
Torrange,  CA  90505
Applicant Contact DAVID FARMAN
Correspondent
Brentwood Instruments, Inc.
3425 Lomita Blvd.
Torrange,  CA  90505
Correspondent Contact DAVID FARMAN
Regulation Number868.1840
Classification Product Code
BZG  
Date Received12/12/1989
Decision Date 03/01/1990
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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