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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 K961783
Device Name SULLIVAN VPAP II ST NASAL VPAP SYSTEM
Applicant
RESMED LTD.
82 WATERLOO RD. NORTH RYDE
SYDNEY, NEW SOUTH WALES,  AU 2113
Applicant Contact HELEN MELER
Correspondent
RESMED LTD.
82 WATERLOO RD. NORTH RYDE
SYDNEY, NEW SOUTH WALES,  AU 2113
Correspondent Contact HELEN MELER
Regulation Number868.5905
Classification Product Code
BZD  
Date Received05/08/1996
Decision Date 08/01/1996
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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