TRILOGY SERIES VENTILATOR WITH OXIMETRY


Device Classification Name

ventilator, continuous, facility use

510(k) Number K111610
Device Name TRILOGY SERIES VENTILATOR WITH OXIMETRY
Applicant
RESPIRONICS, INC.
1740 golden mile highway
monroeville, 
PA 
15146

Applicant Contact joseph e olsavsky
Correspondent
RESPIRONICS, INC.
1740 golden mile highway
monroeville, 
PA 
15146

Correspodent Contact joseph e olsavsky
Regulation Number 868.5895
Classification Product Code
CBK  
Subsequent Product Codes
DQA   NOU  
Date Received 06/09/2011
Decision Date 10/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No