510(k) K072964 ยท GYC Electrode, Cortical
NICOLET CORTICAL STIMULATOR
| Applicant | Cardinal Health, Inc., Stoughton WI, US |
| Decision | Substantially Equivalent, Dec 30, 2008 |
| Received | Oct 19, 2007 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K072964
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2012 | CareFusion 209 Inc. NicoletOne Software v 5.60.2-5.71.4 with Cortical Stimulator License, Catalog/Part Number: 828-056600
Product Usage:
The SSU Amplifier is used with the Cortical Stimulator Control unit which is used Terminated |
GYC | None listed |
| Jan 26, 2012 | CareFusion 209 Inc. Nicolet Cortical Stimulator Control Unit, Catalog/Part Number: 982A0558
Product Usage:
The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping p Terminated |
GYC | None listed |
| Jan 26, 2012 | CareFusion 209 Inc. Nicolet C64 Stimulus Switching Unit (SSU Amplifier), Catalog/ Part Numbers: 382-610800, 688-624200, 688-624300, 842-687900, 672-610800F.
Product Usage:
The SSU Amplifier is used with the Cortical Sti Terminated |
GYC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.