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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K041209
Device Name RESMED S8 PIONEER 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
Correspondent Contact DAVID D'CRUZ
Regulation Number868.5905
Classification Product Code
BZD  
Date Received05/10/2004
Decision Date 07/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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