MAC-LAB/CARDIOLAB EP/COMBOLAB


Device Classification Name

computer, diagnostic, programmable

510(k) Number K021366
Device Name MAC-LAB/CARDIOLAB EP/COMBOLAB
Original Applicant
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 west tower ave.
milwaukee, 
WI 
53223

Original Contact lisa lee michels
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 04/30/2002
Decision Date 07/03/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls