MODIFICATION TO MIRAGE MICRO


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K081321
Device Name MODIFICATION TO MIRAGE MICRO
Applicant
RESMED LTD.
14040 danielson st.
poway, 
CA 
92064 -6857

Applicant Contact david d’cruz
Correspondent
RESMED LTD.
14040 danielson st.
poway, 
CA 
92064 -6857

Correspodent Contact david d’cruz
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 05/12/2008
Decision Date 10/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No