RESMED S8 PRIME CPAP SYSTEM


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K033841
Device Name RESMED S8 PRIME CPAP SYSTEM
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 12/10/2003
Decision Date 03/10/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls