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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 K090863
Device Name PERSONAL WHEEZOMETER
Applicant
KARMELSONIX
31 HAAVODA ST.
BINYAMINA,  IL
Applicant Contact YORAM LEVY
Correspondent
KARMELSONIX
31 HAAVODA ST.
BINYAMINA,  IL
Correspondent Contact YORAM LEVY
Regulation Number868.1900
Classification Product Code
BZM  
Date Received03/30/2009
Decision Date 09/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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