MUSE CARDIOLOGY INFORMATION SYSTEM


Device Classification Name

computer, diagnostic, programmable

510(k) Number K050614
Device Name MUSE CARDIOLOGY INFORMATION SYSTEM
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 west tower ave.
milwaukee, 
WI 
53223

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

Correspodent Contact lisa m baumhardt
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 03/10/2005
Decision Date 04/05/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls