MIRAGE FULL FACE MASK SERIES 2


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K023244
Device Name MIRAGE FULL FACE MASK SERIES 2
Original Applicant
RESMED LTD.
14040 danielson st.
poway, 
CA 
92064 -6857

Original Contact roger kotter
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 09/30/2002
Decision Date 11/27/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No