C2 NASAL MASK


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K033759
Device Name C2 NASAL MASK
Applicant
RESPIRONICS, INC.
1001 murry ridge ln.
murrysville, 
PA 
15668

Applicant Contact zita a yurko
Correspondent
RESPIRONICS, INC.
1001 murry ridge ln.
murrysville, 
PA 
15668

Correspodent Contact zita a yurko
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 12/02/2003
Decision Date 02/19/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No