Myotest DBS Nerve Stimulator
FDA 510(k) K890746 · Biometer Intl. A/S
510(k) numberK890746
Submission
- Device name
- Myotest DBS Nerve Stimulator
- Applicant
- Biometer Intl. A/S
Denmark, DK - Received
- February 13, 1989
- Decision date
- July 14, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BXN – Stimulator, Nerve, Battery-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2775
- Specialty
- Anesthesiology
Other 510(k)s with product code BXN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213049 | STIMPOD NMS450 Nerve StimulatorBXN · Traditional | Xavant Technology (Pty), Ltd. | 10/16/2022SE |
| K162086 | MultiStim ECOBXN · Traditional | PAJUNK GmbH Medizintechnologie | 01/06/2017SE |
| K153045 | SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve StimulatorBXN · Special | Easy Med Instrument Co., Ltd. | 05/13/2016SE |
| K143095 | MiniStim MS-IVB Peripheral Nerve StimulatorBXN · Traditional | Halyard Health, Inc. | 03/24/2015SE |
| K140853 | Stimpod ST2-3010 Nerve StimulatorBXN · Special | Xavant Technology (Pty), Ltd. | 11/06/2014SE |
| K121743 | Easymed Peripheral Nerve Stimulator-SunstinBXN · Traditional | Sunmed, LLC | 03/28/2013SE |
| K111985 | Myoguide System Model 8008BXN · Traditional | Intronix Technologies Corp. | 12/30/2011SE |
| K110118 | Stimtrode Single Use Nerve StimulatorBXN · Special | Xavant Technology (Pty), Ltd. | 02/17/2011SE |
| K102084 | Stimpod NMS450 Nerve StimulatorBXN · Traditional | Xavant Technology (Pty), Ltd. | 12/16/2010SE |
| K093591 | Stimpod Model NMS-400 Nerve StimulatorBXN · Traditional | Xavant Technology (Pty), Ltd. | 12/03/2009SE |
More from Xavant Technology (Pty), Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K925159 | Tof-Guard Transmission MonitorKOI · Traditional | 09/01/1993SE |
| K914231 | Elpha 2000IPF · Traditional | 05/28/1992SE |
| K892396 | Mini Accelograph Neuromuscular Trans. MonitorBXN · Traditional | 10/03/1989SE |
| K893485 | Accelograph Neuromuscular Transmission MonitorBXN · Traditional | 07/28/1989SE |
| K881196 | Am 706 Electromyograph, Stim., Neuro., ExternalIPF · Traditional | 06/16/1989SE |
| K870619 | AccelographBXN · Traditional | 03/16/1987SE |
| K860187 | Myograph 2000 - Neuro. Trans. Monitor & RecordingBXN · Traditional | 03/20/1986SE |
| K860186 | Myotest - Nerve StimulatorBXN · Traditional | 03/20/1986SE |
Questions and answers
When was Myotest DBS Nerve Stimulator cleared by the FDA?
Myotest DBS Nerve Stimulator (K890746) received a 510(k) decision of Substantially Equivalent on July 14, 1989, 151 days after the submission was received.
What is the product code of K890746?
The FDA product code is BXN – Stimulator, Nerve, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 868.2775.