MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM


Device Classification Name

monitor, physiological, patient(with arrhythmia detection or alarms)

510(k) Number K033492
Device Name MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 west tower ave.
milwaukee, 
WI 
53223

Applicant Contact lisa lee michels
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 west tower ave.
milwaukee, 
WI 
53223

Correspodent Contact lisa lee michels
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 11/04/2003
Decision Date 11/24/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No