UNITY NETWORK ID


Device Classification Name

monitor,physiological,patient(without arrhythmia detection or alarms)

510(k) Number K021454
Device Name UNITY NETWORK ID
Original Applicant
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 west tower ave.
milwaukee, 
WI 
53223

Original Contact joelle neider
Regulation Number 870.2300
Classification Product Code
MWI  
Date Received 05/06/2002
Decision Date 10/01/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No