The following data is part of a premarket notification filed by Amplaid Usa, Inc. with the FDA for Evoked Potentials System Mk10.
| Device ID | K832510 |
| 510k Number | K832510 |
| Device Name: | EVOKED POTENTIALS SYSTEM MK10 |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | AMPLAID USA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-27 |
| Decision Date | 1983-11-25 |