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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K101022
Device Name PULMOTRACK 5050 WHOLTER, MODEL 5050
Applicant
Karmelsonix
31 Haavoda St.
Binyamina,  IL
Applicant Contact YORAM LEVY
Correspondent
Karmelsonix
31 Haavoda St.
Binyamina,  IL
Correspondent Contact YORAM LEVY
Regulation Number870.2800
Classification Product Code
DSH  
Date Received04/13/2010
Decision Date 07/09/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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