TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES


Device Classification Name

oximeter

510(k) Number K021955
Device Name TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES
Original Applicant
DATEX-OHMEDA, INC.
1315 west century dr.
louisville, 
CO 
80027

Original Contact michael a chilbert
Regulation Number 870.2700
Classification Product Code
DQA  
Subsequent Product Code
DPZ  
Date Received 06/14/2002
Decision Date 10/08/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No