TABATABA COTESTER


Device Classification Name

analyzer, gas, carbon-monoxide, gaseous-phase

510(k) Number K080278
Device Name TABATABA COTESTER
Applicant
FIM MEDICAL
po box 7007
deerfield, 
IL 
60015

Applicant Contact daniel kamm
Correspondent
FIM MEDICAL
po box 7007
deerfield, 
IL 
60015

Correspodent Contact daniel kamm
Regulation Number 868.1430
Classification Product Code
CCJ  
Date Received 02/04/2008
Decision Date 11/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No