The following data is part of a premarket notification filed by Optax Systems, Inc. with the FDA for Optax System.
| Device ID | K020800 |
| 510k Number | K020800 |
| Device Name: | OPTAX SYSTEM |
| Classification | Recorder, Attention Task Performance |
| Applicant | OPTAX SYSTEMS, INC. 7 TIFFANY TRAIL Hopkinton, MA 01748 |
| Contact | Debbie Iampietro |
| Correspondent | Debbie Iampietro OPTAX SYSTEMS, INC. 7 TIFFANY TRAIL Hopkinton, MA 01748 |
| Product Code | LQD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-12 |
| Decision Date | 2002-06-10 |
| Summary: | summary |