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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous, Minimal Ventilatory Support, Facility Use Ventilator
510(k) Number K974539
Device Name SULLIVAN VPAP II ST VENTILATORY SUPPORT 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 Number868.5895
Classification Product Code
MNT  
Date Received12/03/1997
Decision Date 08/06/1998
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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