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 |