COMFORTGEL FULL FACE MASK


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K073600
Device Name COMFORTGEL FULL FACE MASK
Applicant
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
1001 murry ridge ln.
murrysville, 
PA 
15668

Applicant Contact zita t yurkos
Correspondent
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
1001 murry ridge ln.
murrysville, 
PA 
15668

Correspodent Contact zita t yurkos
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 12/21/2007
Decision Date 04/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No