TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)


Device Classification Name

analyzer, gas, carbon-dioxide, gaseous-phase

510(k) Number K122214
Device Name TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)
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 07/25/2012
Decision Date 05/21/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No