IMAGE3 SE DISPOSABLE FULL FACE MASK


Device Classification Name

ventilator, continuous, facility use

510(k) Number K023135
Device Name IMAGE3 SE DISPOSABLE FULL FACE MASK
Original Applicant
RESPIRONICS, INC.
1001 murry ridge ln.
murrysville, 
PA 
15668

Original Contact zita a yurko
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 09/20/2002
Decision Date 01/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No