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510(k) K931170

SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS) by Sony Medical Systems — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1993
Date Received
March 8, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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