MODIFICATION TO DASH 3000/4000 PATIENT MONITOR


Device Classification Name

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

510(k) Number K030431
Device Name MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 west tower ave.
milwaukee, 
WI 
53223

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

Correspodent Contact karen m lunde
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 02/10/2003
Decision Date 02/26/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No