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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calculator, pulmonary function interpretor (diagnostic)
510(k) Number K071955
Device Name WIM-PC, MODEL 1010
Applicant
KARMEL SONIX
31 HAAVODA ST.
BINYAMINA,  IL
Applicant Contact YORAM LEVY
Correspondent
KARMEL SONIX
31 HAAVODA ST.
BINYAMINA,  IL
Correspondent Contact YORAM LEVY
Regulation Number868.1900
Classification Product Code
BZM  
Date Received07/16/2007
Decision Date 11/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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