Neurovision Ink Printed Endotracheal Tube Electrode
FDA 510(k) K130806 · Neurovision Medical Products, Inc.
510(k) numberK130806
Submission
- Device name
- Neurovision Ink Printed Endotracheal Tube Electrode
- Applicant
- Neurovision Medical Products, Inc.
Ventura, CA, US - Received
- March 25, 2013
- Decision date
- July 12, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PDQ – Neurosurgical Nerve Locator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1820
- Specialty
- Ear, Nose, Throat
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
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More from SurGenTec, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K130570 | Neurovision Medical Motion SensorBZQ · Traditional | 12/26/2013SE |
| K113771 | Signal Gear Urethral Catheter ElectrodeFAP · Traditional | 12/13/2012SE |
| K121931 | Nondisposable Stimulating InstrumentsETN · Traditional | 10/19/2012SE |
| K110989 | Neurovision Ink Printed Endotracheal Tube ElectrodeETN · Traditional | 11/03/2011SE |
| K110140 | Neurovision Nerve Locator MonitorGWF · Traditional | 09/30/2011SE |
| K110712 | Drytouch Suction Stimulator ProbeETN · Traditional | 06/28/2011SE |
| K110138 | Paired Hydrogel ElectrodeETN · Special | 04/08/2011SE |
| K102862 | Neurovision Se (Nerveana)ETN · Traditional | 12/21/2010SE |
Questions and answers
When was Neurovision Ink Printed Endotracheal Tube Electrode cleared by the FDA?
Neurovision Ink Printed Endotracheal Tube Electrode (K130806) received a 510(k) decision of Substantially Equivalent on July 12, 2013, 109 days after the submission was received.
What is the product code of K130806?
The FDA product code is PDQ – Neurosurgical Nerve Locator, a Class II (moderate risk) device regulated under 21 CFR 874.1820.