OXIMETRY INTERFACE KIT


Device Classification Name

ventilator, continuous, non-life-supporting

510(k) Number K111378
Device Name OXIMETRY INTERFACE KIT
Applicant
PHILIPS RESPIRONICS, INC
1740 golden mile highway
monroeville, 
PA 
15146

Applicant Contact elaine larkin
Correspondent
PHILIPS RESPIRONICS, INC
1740 golden mile highway
monroeville, 
PA 
15146

Correspodent Contact elaine larkin
Regulation Number 868.5895
Classification Product Code
MNS  
Date Received 05/17/2011
Decision Date 10/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No