Home / 510(k) Clearances / K904832

510(k) K904832

MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST by Hewlett-Packard Co. — Product Code DXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1991
Date Received
October 23, 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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  • K911384 — CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 (June 25, 1991)
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