Product code GWF
- Device name
- Stimulator, Electrical, Evoked Response
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.1870
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252842 | SafeOp 3: Neural Informatix System | Alphatec Spine, Inc. | 2026-01-11 |
| K243982 | Nicolet EDX | Natus Neurology Incorporated | 2025-01-22 |
| K243495 | Natus Ultrapro S100 (982A0594) | Natus Neurology Incorporated | 2024-12-12 |
| K242345 | Delphi Stimulator | Quantalx Neuroscience | 2024-11-05 |
| K234092 | SafeOp 3: Neural Informatix Systeem | Alphatec Spine, Inc. | 2024-04-19 |
| K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) | Soterix Medical, Inc. | 2024-03-25 |
| K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2023-10-27 |
| K230415 | Cadwell Guardian | Cadwell Industries, Inc. | 2023-08-17 |
| K213849 | SafeOp 2: Neural Informatix System | Alphatec Spine, Inc. | 2022-03-09 |
| K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2022-01-07 |
| K192823 | MEGA-TMS | Soterix Medical, Inc. | 2021-08-13 |
| K190703 | Neuro-IOM system with Neuro-IOM.NET software | Neurosoft , Ltd. | 2021-05-22 |
| K200759 | NIM Vital, Nerve Integrity Monitor | Medtronic Xomed, Inc. | 2020-10-28 |
| K182542 | The EPAD 2 System | Safeop Surgical, Inc. | 2019-02-22 |
| K170677 | Neurovision Nerve Locator Monitor (Nerveana), EMGView Software | Neurovision Medical Product, Inc. | 2017-04-05 |
| K162873 | MEP Monitor | Tonica Elektronik A/S | 2017-03-31 |
| K162199 | Cascade IOMAX Intraoperative Monitor | Cadwell Industries, Inc. | 2017-03-02 |
| K160280 | MagPro R20 | Tonica Elektronik A/S | 2016-05-16 |
| K150220 | STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast | Eb Neuro S.P.A. | 2015-08-19 |
| K142624 | Neuromaster G1 MEE200 | Nihon Kohden Corporation | 2015-04-24 |
| K132616 | EPAD | Safeop Surgical, Inc. | 2014-01-24 |
| K130403 | MAGSTIM DOUBLE 70-2 COIL | The Magstim Company , Ltd. | 2013-08-23 |
| K123843 | NEUROEPG SYSTEM | Strohl Medical Technologies | 2013-06-05 |
| K130346 | SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION | Natus Neurology Incorporated | 2013-05-02 |
| K120397 | MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM | Nihon Kohden Corp. | 2012-09-19 |
| K112881 | NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM) | Nexstim OY | 2012-05-22 |
| K120979 | CAREFUSION NICOLET EDX | Carefusion 209, Inc. | 2012-04-25 |
| K112052 | CAREFUSION NICOLET EDX | Carefusion 209, Inc. | 2012-03-15 |
| K111647 | C2 NERVEMONITOR SYSTEM WITH ACCESSORIES | Inomed Medizintechnik GmbH | 2011-10-06 |
| K110140 | NEUROVISION NERVE LOCATOR MONITOR | Neurovision Medical Products, Inc. | 2011-09-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08056446900215 | NeMus PC PERIPHERAL | EB NEURO SPA | 2019-05-24 |
| 08056446900208 | NeMus SYSTEM | EB NEURO SPA | 2019-05-24 |
| 08033928120958 | Micromed | MICROMED SPA | 2018-05-21 |
| 08033928120880 | micromed | MICROMED SPA | 2018-03-21 |
| 07613327298123 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-23 |
| 07613327298116 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-23 |
| 07613327298093 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-23 |
| 07613327298079 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-23 |
| 07613327298062 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-23 |
| 07613327298055 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-23 |
| 07613327298024 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-23 |
| 07613327298017 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-23 |
| 07613327292190 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-22 |
| 07613327292237 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-22 |
| 07613327292213 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-22 |
| 07613327282207 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-22 |
| 07613327292152 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-22 |
| 07613327292145 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-22 |
| 07613327292138 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-22 |
| 07613327292121 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-22 |
| 07613327292114 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-22 |
| 07613327292107 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-22 |
| 07613327292091 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-22 |
| 07613327292084 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-22 |
| 07613327292077 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-22 |
| 07613327292060 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-22 |
| 07613327282245 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-22 |
| 07613327282238 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-22 |
| 07613327282221 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-22 |
| 07613327282214 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-22 |