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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 K013909
Device Name S7 ELITE CP AP SYSTEM
Applicant
RESMED CORP.
14040 DANIELSON ST.
POWAY,  CA  92064
Applicant Contact ROGER KOTTER
Correspondent
RESMED CORP.
14040 DANIELSON ST.
POWAY,  CA  92064
Correspondent Contact ROGER KOTTER
Regulation Number868.5905
Classification Product Code
BZD  
Date Received11/26/2001
Decision Date 07/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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