The following data is part of a premarket notification filed by Bertec Corp. with the FDA for Eye Trak Tm, Computerized Electronystagmograph (eng), Model Etv-xxxx.
| Device ID | K991642 |
| 510k Number | K991642 |
| Device Name: | EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX |
| Classification | Nystagmograph |
| Applicant | BERTEC CORP. 6185 HUNTLEY RD., SUITE B Columbus, OH 43229 |
| Contact | Doug Morr |
| Correspondent | Doug Morr BERTEC CORP. 6185 HUNTLEY RD., SUITE B Columbus, OH 43229 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-13 |
| Decision Date | 1999-08-03 |