MEM-7102; MEB-7102 Evoked Response & Electro Recor
FDA 510(k) K890274 · Nihon Kohden America, Inc.
510(k) numberK890274
Submission
- Device name
- MEM-7102; MEB-7102 Evoked Response & Electro Recor
- Applicant
- Nihon Kohden America, Inc.
Irvine, CA, US - Received
- January 18, 1989
- Decision date
- May 18, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code GWF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253301 | BraiN20® (BraiN20)GWF · Traditional | Time IS Brain, S.L. | 06/27/2026SE |
| K252842 | SafeOp 3: Neural Informatix SystemGWF · Traditional | Alphatec Spine, Inc. | 01/11/2026SE |
| K243982 | Nicolet EDXGWF · Special | Natus Neurology Incorporated | 01/22/2025SE |
| K243495 | Natus Ultrapro S100 (982A0594)GWF · Special | Natus Neurology Incorporated | 12/12/2024SE |
| K242345 | Delphi StimulatorGWF · Traditional | Quantalx Neuroscience | 11/05/2024SE |
| K234092 | SafeOp 3: Neural Informatix SysteemGWF · Traditional | Alphatec Spine, Inc. | 04/19/2024SE |
| K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)GWF · Traditional | Soterix Medical, Inc. | 03/25/2024SE |
| K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressGWF · Special | Inomed Medizintechnik GmbH | 10/27/2023SE |
| K230415 | Cadwell GuardianGWF · Traditional | Cadwell Industries, Inc. | 08/17/2023SE |
| K213849 | SafeOp 2: Neural Informatix SystemGWF · Traditional | Alphatec Spine, Inc. | 03/09/2022SE |
More from Alphatec Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K113117 | Nihon Kohden EEG-1200A with JE-120A Multi Channel Electrode Junction BoxGWQ · Special | 03/22/2012SE |
| K120485 | Nihon Kohden QP-160 Ak Trend Program with the Addition of Dsa Asymmetry Trend and FFT POMA · Special | 03/16/2012SE |
| K092573 | Nihon Kohden QP-160AK EEG Trend ProgramOMA · Traditional | 07/09/2010SE |
| K083456 | Nihon Kohden CO2 Sensor Kit, Model TG-970PCCK · Special | 03/02/2009SE |
| K083271 | BSM-2300 &BSM6000 with CGS-9001 Series Communication Gateway, Model CGS-9001 Series…MHX · Special | 12/24/2008SE |
| K082785 | Nihon Kohden Bedside Monitor, BSM 9100A SeriesMHX · Special | 11/26/2008SE |
| K071969 | SEN-4100 Electric StimulatorGWF · Traditional | 10/06/2008SE |
| K080546 | Nihon Kohden EEG-1200A Series Neurofax, Model EEG-1200AOLT · Special | 08/29/2008SE |
| K073550 | Prefense EDNS-9000 Series Nurse Central StationMHX · Special | 03/28/2008SE |
| K080342 | Nihon Kohden Bedside Monitor, Model BSM-6000S SeriesMHX · Special | 02/26/2008SE |
Questions and answers
When was MEM-7102; MEB-7102 Evoked Response & Electro Recor cleared by the FDA?
MEM-7102; MEB-7102 Evoked Response & Electro Recor (K890274) received a 510(k) decision of Substantially Equivalent on May 18, 1989, 120 days after the submission was received.
What is the product code of K890274?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.