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 |