MODIFICATION OF APEXPRO TELEMETRY SYSTEM


Device Classification Name

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

510(k) Number K021325
Device Name MODIFICATION OF APEXPRO TELEMETRY SYSTEM
Original Applicant
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 west tower ave.
milwaukee, 
WI 
53223

Original Contact joelle neider
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 04/26/2002
Decision Date 05/07/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No