TRUBLUE NASAL MASK


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K110405
Device Name TRUBLUE NASAL MASK
Applicant
RESPIRONICS, INC.
1001 murry ridge ln.
murrysville, 
PA 
15668

Applicant Contact michelle brinker
Correspondent
RESPIRONICS, INC.
1001 murry ridge ln.
murrysville, 
PA 
15668

Correspodent Contact michelle brinker
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 02/14/2011
Decision Date 06/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No