ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI)


Device Classification Name

display, cathode-ray tube, medical

510(k) Number K073372
Device Name ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI)
Applicant
SYSTEMSONE
6130 blackberry st
ste b
anchorage, 
AK 
99502

Applicant Contact thomas arthur
Regulation Number 870.2450
Classification Product Code
DXJ  
Date Received 12/03/2007
Decision Date 12/07/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No