MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM


Device Classification Name

computer, diagnostic, programmable

510(k) Number K111200
Device Name MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM
Applicant
GE HEALTHCARE
8200 west tower ave
milwaukee, 
WI 
53223

Applicant Contact carol alloian
Correspondent
GE HEALTHCARE
8200 west tower ave
milwaukee, 
WI 
53223

Correspodent Contact carol alloian
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 04/29/2011
Decision Date 10/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No