V200 INTELLI-TRAK OPTION


Device Classification Name

ventilator, continuous, facility use

510(k) Number K110795
Device Name V200 INTELLI-TRAK OPTION
Applicant
RESPIRONICS CALIFORNIA, INC.
3919 william penn highway,
suite 200
murrysville, 
PA 
15668 -8550

Applicant Contact robert m marshall
Correspondent
RESPIRONICS CALIFORNIA, INC.
3919 william penn highway,
suite 200
murrysville, 
PA 
15668 -8550

Correspodent Contact robert m marshall
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 03/22/2011
Decision Date 08/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No