Neurosign 800, 8 Channel Motor Nerve Monitor
FDA 510(k) K980148 · The Magstim Company , Ltd.
510(k) numberK980148
Submission
- Device name
- Neurosign 800, 8 Channel Motor Nerve Monitor
- Applicant
- The Magstim Company , Ltd.
Carmarthenshire, GB - Received
- January 15, 1998
- Decision date
- August 5, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ETN – Stimulator, Nerve
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1820
- Specialty
- Ear, Nose, Throat
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| K253536 | Evala Nerve Stimulator (EPNR002)ETN · Traditional | Epineuron Technologies, Inc. | 02/27/2026SE |
| K251672 | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube…ETN · Traditional | Medtronic Xomed, Inc. | 02/10/2026SE |
| K242852 | ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube…ETN · Traditional | Inomed Medizintechnik GmbH | 06/13/2025SE |
| K233001 | Bioscope Neuromonitor DeviceETN · Traditional | Biosys Biyomedikal Muhendislik San. VE Tic. A.S. | 12/13/2024SE |
| K241917 | EARP Nerve Cuff ElectrodeETN · Special | Retropsoas Technologies, LLC | 07/31/2024SE |
| K232888 | Disposable Laryngeal ElectrodesETN · Traditional | Suzhou Haishen Medical Device Associates Co., Ltd. | 12/21/2023SE |
| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal TubeETN · Special | Medtronic Xomed, Inc. | 10/26/2023SE |
| K230853 | EARP Nerve Cuff ElectrodeETN · Traditional | Nvision Biomedical Technologies, Inc. | 10/06/2023SE |
| K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)ETN · Traditional | Medtronic Xomed, Inc. | 08/30/2023SE |
| K223254 | C2 XploreETN · Traditional | Inomed Medizintechnik GmbH | 01/27/2023SE |
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| K211389 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0…OBP · Traditional | 09/14/2021SE |
| K203684 | Neurosign V4 Intraoperative Nerve MonitorPDQ · Traditional | 03/17/2021SE |
| K183376 | HORIZON TMS Therapy System with NavigationOBP · Traditional | 04/03/2019SE |
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Questions and answers
When was Neurosign 800, 8 Channel Motor Nerve Monitor cleared by the FDA?
Neurosign 800, 8 Channel Motor Nerve Monitor (K980148) received a 510(k) decision of Substantially Equivalent on August 5, 1998, 202 days after the submission was received.
What is the product code of K980148?
The FDA product code is ETN – Stimulator, Nerve, a Class II (moderate risk) device regulated under 21 CFR 874.1820.