APEXPRO TELEMETRY SYSTEMS


Device Classification Name

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

510(k) Number K080251
Device Name APEXPRO TELEMETRY SYSTEMS
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 west tower ave.
milwaukee, 
WI 
53223

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

Correspodent Contact bernard sandler
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 01/31/2008
Decision Date 06/20/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls