The following data is part of a premarket notification filed by Amplaid Usa, Inc. with the FDA for Visual Pattern Reversal Gen. & Photic S..
| Device ID | K810481 |
| 510k Number | K810481 |
| Device Name: | VISUAL PATTERN REVERSAL GEN. & PHOTIC S. |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | AMPLAID USA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-23 |
| Decision Date | 1981-03-11 |