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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 K123148
Device Name PARACE MD EKOSCOPE IS100
Applicant
Parace, LLC
P.O. Box 171
Yorktown Heights,  NY  10598
Applicant Contact VANDETTE CARTER
Correspondent
Parace, LLC
P.O. Box 171
Yorktown Heights,  NY  10598
Correspondent Contact VANDETTE CARTER
Regulation Number870.1875
Classification Product Code
DQD  
Date Received10/05/2012
Decision Date 11/19/2013
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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