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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 K984428
Device Name SULLIVAN AUTOSET NASAL CPAP SYSTEM
Applicant
Resmed, Ltd.
10121 Carroll Canyon Rd.
San Diego,  CA  92131
Applicant Contact SCOTT DUDEVOIR
Correspondent
Resmed, Ltd.
10121 Carroll Canyon Rd.
San Diego,  CA  92131
Correspondent Contact SCOTT DUDEVOIR
Regulation Number868.5905
Classification Product Code
BZD  
Date Received12/04/1998
Decision Date 07/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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