The following data is part of a premarket notification filed by Eyetect, L.l.c. with the FDA for Eyetect Tremor Monitor Unit (tmu).
| Device ID | K003644 |
| 510k Number | K003644 |
| Device Name: | EYETECT TREMOR MONITOR UNIT (TMU) |
| Classification | Nystagmograph |
| Applicant | EYETECT, L.L.C. 10 MADONNA COURT Belleville,, IL 62223 |
| Contact | Rebecca M Cueto |
| Correspondent | Rebecca M Cueto EYETECT, L.L.C. 10 MADONNA COURT Belleville,, IL 62223 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-27 |
| Decision Date | 2001-02-01 |