MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM


Device Classification Name

electrocardiograph

510(k) Number K073625
Device Name MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM
Applicant
GE HEALTHCARE SYSTEMS INFORMATION TECHNOLOGIES
9900 innovation drive
wauwatosa, 
WI 
53226

Applicant Contact margaret mucha
Correspondent
GE HEALTHCARE SYSTEMS INFORMATION TECHNOLOGIES
9900 innovation drive
wauwatosa, 
WI 
53226

Correspodent Contact margaret mucha
Regulation Number 870.2340
Classification Product Code
DPS  
Subsequent Product Codes
DHX   DQK  
Date Received 12/26/2007
Decision Date 01/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No