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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 K010761
Device Name SPL-50 SPIROLYSER
Applicant
Fim Medical
30 Rue Camille
Lyon,  FR 69003
Applicant Contact ERIC DEREI
Correspondent
Fim Medical
30 Rue Camille
Lyon,  FR 69003
Correspondent Contact ERIC DEREI
Regulation Number868.1840
Classification Product Code
BZG  
Date Received03/13/2001
Decision Date 03/05/2002
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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