The following data is part of a premarket notification filed by Eye Dynamics, Inc. with the FDA for House Infrared/video Electronystagmograph System.
| Device ID | K925111 |
| 510k Number | K925111 |
| Device Name: | HOUSE INFRARED/VIDEO ELECTRONYSTAGMOGRAPH SYSTEM |
| Classification | Nystagmograph |
| Applicant | EYE DYNAMICS, INC. 2291 205TH STREET, SUITE 203 Torrance, CA 90501 |
| Contact | Ronald A Waldorf |
| Correspondent | Ronald A Waldorf EYE DYNAMICS, INC. 2291 205TH STREET, SUITE 203 Torrance, CA 90501 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-09 |
| Decision Date | 1994-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B292M9205200 | K925111 | 000 |
| B292M9203020 | K925111 | 000 |
| B292M9174150 | K925111 | 000 |
| B292M9170810 | K925111 | 000 |
| B2924091070 | K925111 | 000 |
| B2924040100 | K925111 | 000 |