MODIFICATION TO SOLAR 9500 INFORMATION MONITOR


Device Classification Name

monitor, physiological, patient(with arrhythmia detection or alarms)

510(k) Number K030575
Device Name MODIFICATION TO SOLAR 9500 INFORMATION MONITOR
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 west tower ave.
milwaukee, 
WI 
53223

Applicant Contact andrew kluessendorf
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 west tower ave.
milwaukee, 
WI 
53223

Correspodent Contact andrew kluessendorf
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 02/24/2003
Decision Date 03/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls