The following data is part of a premarket notification filed by Hill-rom Services Pte Ltd with the FDA for Metaneb.
Device ID | K124032 |
510k Number | K124032 |
Device Name: | METANEB |
Classification | Device, Positive Pressure Breathing, Intermittent |
Applicant | HILL-ROM SERVICES PTE LTD 1 YISHUN AVE 7 Singapore, SG 768923 |
Contact | Paul Dryden |
Correspondent | Paul Dryden HILL-ROM SERVICES PTE LTD 1 YISHUN AVE 7 Singapore, SG 768923 |
Product Code | NHJ |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-28 |
Decision Date | 2013-04-25 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
METANEB 85015197 3879967 Live/Registered |
Comedica Incorporated 2010-04-15 |
METANEB 78795043 3314255 Live/Registered |
Comedica Incorporated 2006-01-19 |
METANEB 77158684 3364777 Dead/Cancelled |
Comedica Incorporated 2007-04-17 |