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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 K140124
Device Name S9 ELOUERA
Applicant
RESMED CORP
9001 Spectrum Center Boulevard
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San Diego,  CA  92123
Applicant Contact JIM CASSI
Correspondent
RESMED CORP
9001 Spectrum Center Boulevard
--
San Diego,  CA  92123
Correspondent Contact JIM CASSI
Regulation Number868.5905
Classification Product Code
BZD  
Subsequent Product Code
MNR  
Date Received01/16/2014
Decision Date 05/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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