MAC 5500 HD, MAC 3500


Device Classification Name

electrocardiograph

510(k) Number K110266
Device Name MAC 5500 HD, MAC 3500
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC
9900 inovation drive
wauwatosa, 
WI 
53226

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

Correspodent Contact patricia taige
Regulation Number 870.2340
Classification Product Code
DPS  
Subsequent Product Codes
DQK   DXH  
Date Received 01/28/2011
Decision Date 04/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No