The following data is part of a premarket notification filed by Isen Tech & Trading Company, Ltd. with the FDA for Isen-goggles.
| Device ID | K152727 |
| 510k Number | K152727 |
| Device Name: | ISEN-Goggles |
| Classification | Nystagmograph |
| Applicant | ISEN TECH & TRADING COMPANY, LTD. RM509, BLDG A, CYBER TOWER, NO. 2 ZHONGGUANCUN SOUTH AVE Beijing, CN 100086 |
| Contact | Martin Liu |
| Correspondent | Linda J Bovard Bovard Consulting LLC 378 HARDY AVENUE Eugene, OR 97404 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-22 |
| Decision Date | 2016-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B499V062 | K152727 | 000 |