The following data is part of a premarket notification filed by Vestibular First with the FDA for Insight Infrared Video Goggles.
| Device ID | K203082 |
| 510k Number | K203082 |
| Device Name: | Insight Infrared Video Goggles |
| Classification | Nystagmograph |
| Applicant | Vestibular First 9 Mather Ave Broomall, PA 19008 |
| Contact | Helena Esmonde |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-10-13 |
| Decision Date | 2020-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10860002280735 | K203082 | 000 |
| 10860002280742 | K203082 | 000 |
| 00860002280714 | K203082 | 000 |