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510(k) K883888

CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. by Advanced Biosearch Assn. — Product Code DXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1988
Date Received
September 15, 1988
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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