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510(k) K901658

ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND by Hitachi Medical Corp. of America — Product Code DXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1990
Date Received
April 10, 1990
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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  • K945400 — HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100 (November 20, 1995)

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