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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 K031517
Device Name ZARGIS ACOUSTIC CARDIOSCAN
Applicant
Zargis Medical Corp.
755 College Rd. E.
Princeton,  NJ  08540
Applicant Contact SHAHRAM HEJAZI
Correspondent
Zargis Medical Corp.
755 College Rd. E.
Princeton,  NJ  08540
Correspondent Contact SHAHRAM HEJAZI
Regulation Number870.1875
Classification Product Code
DQD  
Subsequent Product Code
DQC  
Date Received05/15/2003
Decision Date 05/26/2004
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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