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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic
510(k) Number K862913
Device Name CARDIOSCAN WITH DOPPLER OPTION
Applicant
Interspec, Inc.
1100 E. Hector St.
Conshohocken,  PA  19428
Applicant Contact SCHAFER, M.SC.
Correspondent
Interspec, Inc.
1100 E. Hector St.
Conshohocken,  PA  19428
Correspondent Contact SCHAFER, M.SC.
Regulation Number870.2880
Classification Product Code
JOP  
Date Received08/01/1986
Decision Date 11/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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