HUMIDAIRE 2I


Device Classification Name

humidifier, respiratory gas, (direct patient interface)

510(k) Number K080797
Device Name HUMIDAIRE 2I
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 868.5450
Classification Product Code
BTT  
Date Received 03/20/2008
Decision Date 07/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No