PERFORMAX SE TOTAL FACE MASK


Device Classification Name

ventilator, continuous, facility use

510(k) Number K072588
Device Name PERFORMAX SE TOTAL FACE MASK
Applicant
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
1001 murry ridge ln.
murrysville, 
PA 
15668

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

Correspodent Contact zita yurko
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 09/14/2007
Decision Date 12/18/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No