CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110


Device Classification Name

ventilator, continuous, facility use

510(k) Number K072885
Device Name CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110
Applicant
DRAEGER MEDICAL AG & CO. KG
3135 quarry road
telford, 
PA 
18969

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

Correspodent Contact kathy anderson
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 10/09/2007
Decision Date 04/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No