MAC 600 RESTING ECG ANALYSIS SYSTEM


Device Classification Name

electrocardiograph

510(k) Number K103765
Device Name MAC 600 RESTING ECG ANALYSIS SYSTEM
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC
9900 inovation drive
wauwatosa, 
WI 
53226

Applicant Contact joe lucas
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC
9900 inovation drive
wauwatosa, 
WI 
53226

Correspodent Contact joe lucas
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 12/23/2010
Decision Date 05/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No