Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K140124
Device Name S9 ELOUERA
Applicant
RESMED CORP
9001 Spectrum Center Boulevard
--
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
-
-