MODIFICATION TO VIEWMATE SYSTEM


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K073709
Device Name MODIFICATION TO VIEWMATE SYSTEM
Applicant
EP MEDSYSTEMS
cooper run executive park
575 route 73 n. bldg. d
west berlin, 
NJ 
08091

Applicant Contact larry picciano
Correspondent
EP MEDSYSTEMS
cooper run executive park
575 route 73 n. bldg. d
west berlin, 
NJ 
08091

Correspodent Contact larry picciano
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   OBJ  
Date Received 12/31/2007
Decision Date 03/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No