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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K090493
Device Name SIGNAL
Applicant
Zargis Medical Corp.
2 Research Way, 1st Floor
Princeton,  NJ  08540
Applicant Contact JOHN KALLASSY
Correspondent
Zargis Medical Corp.
2 Research Way, 1st Floor
Princeton,  NJ  08540
Correspondent Contact JOHN KALLASSY
Regulation Number870.1875
Classification Product Code
DQD  
Date Received02/25/2009
Decision Date 08/07/2009
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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