ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000


Device Classification Name

ventilator, continuous, facility use

510(k) Number K111116
Device Name ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000
Applicant
DATEX-OHMEDA
po box 7550
3030 ohmeda dr
madison, 
WI 
53707

Applicant Contact monica morrison
Correspondent
DATEX-OHMEDA
po box 7550
3030 ohmeda dr
madison, 
WI 
53707

Correspodent Contact monica morrison
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 04/21/2011
Decision Date 09/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls