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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 K984031
Device Name SPIROVIT, MODEL SP-250
Applicant
Schiller AG
Altgasse 68
Baar,  CH CH-6341
Applicant Contact MARKUS BUETLER
Correspondent
Schiller AG
Altgasse 68
Baar,  CH CH-6341
Correspondent Contact MARKUS BUETLER
Regulation Number868.1840
Classification Product Code
BZG  
Date Received11/12/1998
Decision Date 04/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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