510(k) K073709

MODIFICATION TO VIEWMATE SYSTEM by Ep Medsystems — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2008
Date Received
December 31, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type