The following data is part of a premarket notification filed by Isent Tech & Trading Company,ltd. with the FDA for Isen-goggles With Data Viewer.
| Device ID | K163270 |
| 510k Number | K163270 |
| Device Name: | ISEN-Goggles With Data Viewer |
| Classification | Nystagmograph |
| Applicant | ISENT TECH & TRADING COMPANY,LTD. RM509, BLDG A, CYBERTOWER, NO.2 ZHONGGUANCUN S AVE Beijing, CN 100086 |
| Contact | Martin Liu |
| Correspondent | Tim Renner VISION28 915 SW RIMROCK WAY, STE 201 PMB 402 Redmond, OR 97756 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-21 |
| Decision Date | 2017-09-25 |
| Summary: | summary |