510(k) K152505 ยท ETN Stimulator, Nerve
C2 NerveMonitor System
| Applicant | Inomed Medizintechnik GmbH, Emmendingen Baden- Wuerttemberg, DE |
| Decision | Substantially Equivalent, Feb 1, 2016 |
| Received | Sep 2, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152505
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2019 | Stryker Instruments Div. of Stryker Corporation C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329
Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identificatio Terminated |
ETN | None listed |
| Jul 31, 2019 | Stryker Instruments Div. of Stryker Corporation C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319
Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identificatio Terminated |
ETN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.