The following data is part of a premarket notification filed by Neurovision Medical Products, Inc. with the FDA for Neurovision Ink Printed Endotracheal Tube Electrode.
| Device ID | K130806 |
| 510k Number | K130806 |
| Device Name: | NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE |
| Classification | Neurosurgical Nerve Locator |
| Applicant | NEUROVISION MEDICAL PRODUCTS, INC. 2225 SPERRY AVE, SUITE 1000 Ventura, CA 93003 |
| Contact | Christine Vergely |
| Correspondent | Christine Vergely NEUROVISION MEDICAL PRODUCTS, INC. 2225 SPERRY AVE, SUITE 1000 Ventura, CA 93003 |
| Product Code | PDQ |
| Subsequent Product Code | BTR |
| Subsequent Product Code | ETN |
| Subsequent Product Code | GWF |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-25 |
| Decision Date | 2013-07-12 |
| Summary: | summary |