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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 K896120
Device Name SCHILLER MODEL SP-100 SPIROVIT(TM)
Applicant
Schiller America, Inc.
3002 Dow Ave. #122
Tustin,  CA  92680
Applicant Contact J FLETCHER
Correspondent
Schiller America, Inc.
3002 Dow Ave. #122
Tustin,  CA  92680
Correspondent Contact J FLETCHER
Regulation Number868.1840
Classification Product Code
BZG  
Date Received10/24/1989
Decision Date 01/09/1990
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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