MONARCH II MINI MASK


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K992336
Device Name MONARCH II MINI MASK
Applicant
RESPIRONICS, INC.
1001 murry ridge ln.
murrysville, 
PA 
15668

Applicant Contact david j vanella
Correspondent
RESPIRONICS, INC.
1001 murry ridge ln.
murrysville, 
PA 
15668

Correspodent Contact david j vanella
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 07/13/1999
Decision Date 08/13/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No