SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585


Device Classification Name

ventilator, continuous, facility use

510(k) Number K073179
Device Name SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585
Applicant
MAQUET CRITICAL CARE AB
1140 route 22 east
suite 202
bridgewater, 
NJ 
08807

Applicant Contact jamie yieh
Correspondent
MAQUET CRITICAL CARE AB
1140 route 22 east
suite 202
bridgewater, 
NJ 
08807

Correspodent Contact jamie yieh
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 11/13/2007
Decision Date 06/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls