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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 K970771
Device Name SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM
Applicant
RESMED LTD.
82 WATERLOO RD. NORTH RYDE
SYDNEY, NEW SOUTH WALES,  AU 2113
Applicant Contact MICHAEL HALLETT
Correspondent
RESMED LTD.
82 WATERLOO RD. NORTH RYDE
SYDNEY, NEW SOUTH WALES,  AU 2113
Correspondent Contact MICHAEL HALLETT
Regulation Number868.5905
Classification Product Code
BZD  
Date Received03/03/1997
Decision Date 06/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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