The following data is part of a premarket notification filed by Neuro Kinetics, Inc. with the FDA for I-portal Notc, Vng And Vog.
| Device ID | K143607 |
| 510k Number | K143607 |
| Device Name: | I-Portal NOTC, VNG And VOG |
| Classification | Nystagmograph |
| Applicant | NEURO KINETICS, INC. 128 GAMMA DRIVE Pittsburgh, PA 15238 |
| Contact | J. Howison Schroeder |
| Correspondent | J. Howison Schroeder NEURO KINETICS, INC. 128 GAMMA DRIVE Pittsburgh, PA 15238 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-19 |
| Decision Date | 2015-07-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B290SVNG1 | K143607 | 000 |
| B290SVNG0 | K143607 | 000 |
| B290NOTC0 | K143607 | 000 |
| B818SVNG0 | K143607 | 000 |