510(k) K850290

ULTRASOUND GEL by Litton Datamedix — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1985
Date Received
January 24, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type