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 |