T-WAVE ALTERMANS (TWA) ALGORITHM OPTION


Device Classification Name

computer, diagnostic, programmable

510(k) Number K023380
Device Name T-WAVE ALTERMANS (TWA) ALGORITHM OPTION
Original Applicant
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 west tower ave.
milwaukee, 
WI 
53223

Original Contact david wahlig
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 10/08/2002
Decision Date 12/03/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No