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510(k) K911384

CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 by Endosonics Corp. — Product Code DXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1991
Date Received
March 28, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Echocardiograph
Device Class
Class II
Regulation Number
870.2330
Review Panel
CV
Submission Type

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