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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K931170
Device Name SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS)
Applicant
Sony Medical Systems
C/O Medical Device Consult,Inc
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact CYNTHIA A SINCLAIR
Correspondent
Sony Medical Systems
C/O Medical Device Consult,Inc
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact CYNTHIA A SINCLAIR
Regulation Number892.1600
Classification Product Code
IZI  
Date Received03/08/1993
Decision Date 06/14/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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