510(k) K002765 ยท GWM Device, Monitoring, Intracranial Pressure
LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE
| Applicant | Integra Neurosciences, San Diego CA, US |
| Decision | Substantially Equivalent, Nov 24, 2000 |
| Received | Sep 5, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002765
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2014 | Integra LifeSciences Corp. Integra Licox Brain Tissue Oxygen Monitoring
Integra Licox Recon Tissue Oxygen Monitoring
1) LICOX Complete Brain Probe Kit (comprised of IP1, CC1.P1)
2) LICOX Complete Brain Probe Kit (comprised of Terminated |
GWM | None listed |
| Mar 3, 2011 | Integra LifeSciences Corp. LICOX CMP Tissue Oxygen Monitor; Catalog numbers REF AC31. Manufacturer GMS Gesellschaft fur medizinische, Sondentechnik mbH, Dorfstrasse 2, 24247 Mielkendorf, Germany; Distributed by Integra NeuroSc Terminated |
GWM | None listed |
| Mar 15, 2005 | Integra Neuro Sciences LICOX Complete Brain IMC Probe Kit, Model IM3.ST C Terminated |
GMW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.