The following data is part of a premarket notification filed by Amplaid Usa, Inc. with the FDA for Amplaid Mark 4 And Mark 5.
| Device ID | K781667 |
| 510k Number | K781667 |
| Device Name: | AMPLAID MARK 4 AND MARK 5 |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | AMPLAID USA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-25 |
| Decision Date | 1978-11-03 |