510(k) K131184 ยท GWM Device, Monitoring, Intracranial Pressure
INTEGRA LICOX PTO2 MONITOR
| Applicant | Integra Lifesciences Corp., Burlington MA, US |
| Decision | Substantially Equivalent, Aug 30, 2013 |
| Received | Apr 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131184
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 15, 2015 | Integra LifeSciences Corp. The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters.
The CAM02 monitor measures and displa Terminated |
GWM | None listed |
| May 15, 2015 | Integra LifeSciences Corp. The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters.
The LCX02 monitor measures and displa Terminated |
GWM | None listed |
| May 15, 2015 | Integra LifeSciences Corp. The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters.
The LCX02R monitor measures and displ Terminated |
GWM | None listed |
| Nov 10, 2014 | Integra LifeSciences Corp. Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeScien Terminated |
GWM | None listed |
| May 30, 2014 | Integra LifeSciences Corp. Integra Licox Test Kit REF BC10R Rx Only
An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with a secondary means to verify the monitor's PtO2 state-of-calibrati Terminated |
GWM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.