NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912
HILL-ROM MANUFACTURING, INC.
HILL-ROM MANUFACTURING, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2183816 | 2183816 | HILL-ROM MANUFACTURING, INC. | 1 | N | 2026-01-01 | 1020 COUNTY ROAD F W SAINT PAUL MN US 55126 |
| 2183816 | 2183816 | HILL-ROM MANUFACTURING, INC. | 1 | Y | 2020-04-25 | 1020 COUNTY ROAD F W SAINT PAUL MN US 55126 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 3908 | 1003985454 | K993629 | ABI VEST AIRWAY CLEARANCE SYSTEM | BYI | 2000-01-21 |
| 301350 | 1086318445 | K233441 | The Vest APX System (PVAPX1) | BYI | 2024-03-22 |
| 301350 | 1424471251 | K200988 | Maximus System | NHJ | 2020-05-26 |
| 3908 | 1767516204 | K192143 | Maximus System | NHJ | 2020-02-14 |
| 301350 | 1912065477 | K192143 | Maximus System | NHJ | 2020-02-14 |
| 3908 | 1951177096 | K170037 | Breathe Technologies Life2000™ Ventilation System | CBK | 2017-08-11 |
| 301350 | 1165186955 | K163378 | Monarch Airway Clearance System | BYI | 2017-03-17 |
| 3908 | 2014225634 | K163378 | Monarch Airway Clearance System | BYI | 2017-03-17 |
| 3908 | 1639053740 | K151689 | MetaNeb 4 System | NHJ | 2016-03-17 |
| 301350 | 1928620504 | K151689 | MetaNeb 4 System | NHJ | 2016-03-17 |
| 3908 | 1038792434 | K142482 | The Vest Airway Clearance System | BYI | 2015-05-07 |
| 301350 | 1999661390 | K142482 | The Vest Airway Clearance System | BYI | 2015-05-07 |
| 3908 | 1105118268 | K141943 | BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM | CBK | 2015-06-12 |
| 301350 | 2025818617 | K132988 | VITAL COUGH | NHJ | 2014-03-28 |
| 3908 | 1023110398 | K124032 | METANEB | NHJ | 2013-04-25 |
| 301350 | 2067501449 | K124032 | METANEB | NHJ | 2013-04-25 |
| 3908 | 1703038559 | K120277 | VITAL COUGH | NHJ | 2012-09-12 |
| 3908 | 1814676448 | K102525 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) | ONZ | 2010-12-02 |
| 3908 | 1148353166 | K100528 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S | ONZ | 2010-04-23 |
| 3908 | 1543397542 | K082982 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES | ONZ | 2009-07-20 |
| 3908 | 1069915598 | K051964 | POWERNEB | NHJ | 2005-12-01 |
| 301350 | 1239690772 | K051964 | POWERNEB | NHJ | 2005-12-01 |
| 3908 | 1457070830 | K024309 | THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104 | BYI | 2003-02-21 |
| 301350 | 1958919645 | K024309 | THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104 | BYI | 2003-02-21 |
| 3908 | 1210950960 |
Product Codes Associated With Registrations#
PMN#
MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM
HILL-ROM MANUFACTURING, INC.
ISOLETTE INFANT INCUBATOR, MODEL C2000E
HILL-ROM MANUFACTURING, INC.
MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM
HILL-ROM MANUFACTURING, INC.