DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC


Device Classification Name

analyzer, gas, oxygen, gaseous-phase

510(k) Number K051092
Device Name DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC
Applicant
GE HEALTHCARE
86 pilgrim road
needham, 
MA 
02492

Applicant Contact joel c kent
Correspondent
GE HEALTHCARE
86 pilgrim road
needham, 
MA 
02492

Correspodent Contact joel c kent
Regulation Number 868.1720
Classification Product Code
CCL  
Subsequent Product Codes
BZK   BZL   CAP   CBQ   CBR  
CBS   NHO   NHP   NHQ  
Date Received 04/28/2005
Decision Date 05/25/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls