The following data is part of a premarket notification filed by E-z Instruments Co. with the FDA for Rub E-z.
| Device ID | K854396 |
| 510k Number | K854396 |
| Device Name: | RUB E-Z |
| Classification | Tester, Electrode/lead, Electroencephalograph |
| Applicant | E-Z INSTRUMENTS CO. P.O. BOX 680263 San Antonio, TX 78268 |
| Contact | Kenneth R Hartman |
| Correspondent | Kenneth R Hartman E-Z INSTRUMENTS CO. P.O. BOX 680263 San Antonio, TX 78268 |
| Product Code | GYA |
| CFR Regulation Number | 882.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-31 |
| Decision Date | 1986-05-08 |