510(k) K934887

9750 ATHENA ETHERNET OPTION by S & W Medico Teknik A/S — Product Code DXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1994
Date Received
October 12, 1993
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