The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi Eh-11.
| Device ID | K834059 |
| 510k Number | K834059 |
| Device Name: | FUKUDA DENSHI EH-11 |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | FUKUDA DENSHI USA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-25 |
| Decision Date | 1985-06-21 |