AirRay Subdural Cortical Electrodes— 510(k) K183437
Substantially EquivalentCortec GmbH
FDA 510(k) clearance K183437 for AirRay Subdural Cortical Electrodes, Substantially Equivalent on 2019-03-12. Applicant: Cortec GmbH. Device class: 2.
Clearance details
- Applicant
- Cortec GmbH
- Product code
- Code GYC
- Device class
- Class 2
- Regulation
- 21 CFR 882.1310
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Freiburg, DE
Recent devices under product code GYC
view all- K250094 — Atlas Stim Headbox (NK) (31-0601-0077) +9 more
- K242618 — Layer 7-T
- K221123 — WISE Cortical Strip (WCS)
- K211954 — Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid
- K201931 — Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
Data sourced from openFDA. This site is unofficial and independent of the FDA.