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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 K013843
Device Name AUTOSET SPIRIT CPAP SYSTEM
Applicant
ResMed Corp
14040 Danielson St.
Poway,  CA  92064 -6857
Applicant Contact ROGER KOTTER
Correspondent
ResMed Corp
14040 Danielson St.
Poway,  CA  92064 -6857
Correspondent Contact ROGER KOTTER
Regulation Number868.5905
Classification Product Code
BZD  
Date Received11/20/2001
Decision Date 07/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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