The following data is part of a premarket notification filed by Vertigone, Inc. with the FDA for Vertigone Bppv Goggle.
| Device ID | K082634 |
| 510k Number | K082634 |
| Device Name: | VERTIGONE BPPV GOGGLE |
| Classification | Apparatus, Vestibular Analysis |
| Applicant | VERTIGONE, INC. 2202 TIMBERLOCH PLACE SUITE 230 Woodlands, TX 77380 |
| Contact | Jaye Thompson |
| Correspondent | Jaye Thompson VERTIGONE, INC. 2202 TIMBERLOCH PLACE SUITE 230 Woodlands, TX 77380 |
| Product Code | LXV |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-10 |
| Decision Date | 2009-04-07 |
| Summary: | summary |