The following data is part of a premarket notification filed by General Devices with the FDA for Ap-check.
| Device ID | K830877 |
| 510k Number | K830877 |
| Device Name: | AP-CHECK |
| Classification | Tester, Electrode/lead, Electroencephalograph |
| Applicant | GENERAL DEVICES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GYA |
| CFR Regulation Number | 882.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-18 |
| Decision Date | 1983-06-08 |