OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500


Device Classification Name

ventilator, continuous, facility use

510(k) Number K072412
Device Name OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500
Applicant
DRAGER MEDICAL AG & CO. KGAA
3135 quarry road
telford, 
PA 
18969

Applicant Contact kathy anderson
Correspondent
DRAGER MEDICAL AG & CO. KGAA
3135 quarry road
telford, 
PA 
18969

Correspodent Contact kathy anderson
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 08/27/2007
Decision Date 02/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No