DASH 2500 PATIENT MONITOR


Device Classification Name

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

510(k) Number K080157
Device Name DASH 2500 PATIENT MONITOR
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 west tower ave.
milwaukee, 
WI 
53223

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

Correspodent Contact sharon untz
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 01/23/2008
Decision Date 03/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No