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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, positive pressure breathing, intermittent
510(k) Number K124032
Device Name METANEB
Applicant
HILL-ROM SERVICES PTE LTD
1 YISHUN AVE 7
SINGAPORE,  SG 768923
Applicant Contact PAUL DRYDEN
Correspondent
HILL-ROM SERVICES PTE LTD
1 YISHUN AVE 7
SINGAPORE,  SG 768923
Correspondent Contact PAUL DRYDEN
Regulation Number868.5905
Classification Product Code
NHJ  
Date Received12/28/2012
Decision Date 04/25/2013
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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