GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS


Device Classification Name

analyzer, gas, carbon-dioxide, gaseous-phase

510(k) Number K110594
Device Name GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS
Applicant
NIHON KOHDEN CORP.
90 icon street
foothill ranch, 
CA 
92610

Applicant Contact steve geerdes
Correspondent
NIHON KOHDEN CORP.
90 icon street
foothill ranch, 
CA 
92610

Correspodent Contact steve geerdes
Regulation Number 868.1400
Classification Product Code
CCK  
Date Received 03/02/2011
Decision Date 10/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No