S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K024191
Device Name S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK
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 12/20/2002
Decision Date 07/02/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No