Nerve Integrity MONITOR-2 (NIM-2 XL)
FDA 510(k) K934426 · Xomed-Treace, Inc.
510(k) numberK934426
Submission
- Device name
- Nerve Integrity MONITOR-2 (NIM-2 XL)
- Applicant
- Xomed-Treace, Inc.
Jacksonville, FL, US - Received
- September 10, 1993
- Decision date
- May 13, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
Other 510(k)s with product code ETN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Inomed Medizintechnik GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K940028 | Endoscope SheathEOB · Traditional | 03/24/1995SE |
| K941407 | Tympanostomy (Ventilation) TubeETD · Traditional | 03/14/1995SE |
| K945659 | Blackstar(Tm) Star SystemERL · Traditional | 01/09/1995SE |
| K932771 | Battery Powered, Disposable Endoscope Light SourceEQH · Traditional | 08/24/1994SE |
| K933672 | Xomed-Treace ScopesheathEOB · Traditional | 07/18/1994SE |
| K933105 | Xomed-Treace Rigid Rod Lens EndoscopeEOB · Traditional | 01/05/1994SE |
| K925640 | Xomed-Treace Emg Endotracheal TubeenETN · Traditional | 08/17/1993SE |
| K922880 | Xomed Treace Jet Ventilation TubeBTR · Traditional | 04/15/1993SE |
| K923830 | Xomed-Treace AlphascopeERA · Traditional | 11/09/1992SE |
| K912753 | Xomed-Treace Positrol Footpedal Suction ControlGCX · Traditional | 09/23/1991SE |
Questions and answers
When was Nerve Integrity MONITOR-2 (NIM-2 XL) cleared by the FDA?
Nerve Integrity MONITOR-2 (NIM-2 XL) (K934426) received a 510(k) decision of Substantially Equivalent on May 13, 1994, 245 days after the submission was received.
What is the product code of K934426?
The FDA product code is ETN – Stimulator, Nerve, a Class II (moderate risk) device regulated under 21 CFR 874.1820.