SMART BREATH RESPIRATORY COMPENSATION OPTION


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K022919
Device Name SMART BREATH RESPIRATORY COMPENSATION OPTION
Original Applicant
GE MEDICAL SYSTEMS
p.o. 414
milwaukee, 
WI 
53201

Original Contact larry a kroger
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 09/04/2002
Decision Date 09/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No