MAC 1600 ECG ANALYSIS SYSTEM


Device Classification Name

electrocardiograph

510(k) Number K081437
Device Name MAC 1600 ECG ANALYSIS SYSTEM
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
9900 innovation dr.
rp-2122
wauwatosa, 
WI 
53226

Applicant Contact margaret mucha
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
9900 innovation dr.
rp-2122
wauwatosa, 
WI 
53226

Correspodent Contact margaret mucha
Regulation Number 870.2340
Classification Product Code
DPS  
Subsequent Product Codes
DQK   DXH  
Date Received 05/22/2008
Decision Date 07/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No