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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 K970516
Device Name SULLIVAN AUTOSET HOME 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 Received02/11/1997
Decision Date 05/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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