510(k) K896543

ULTRAMARK 7 ULTRASOUND SYSTEM by Advanced Technology Laboratories, Inc. — Product Code DXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1990
Date Received
November 17, 1989
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