The following data is part of a premarket notification filed by Kindel & Anderson with the FDA for Rion Electro-palatograph Model Dp-01.
| Device ID | K802870 |
| 510k Number | K802870 |
| Device Name: | RION ELECTRO-PALATOGRAPH MODEL DP-01 |
| Classification | Aids, Speech Training For The Hearing Impaired (ac-powered And Patient-contact) |
| Applicant | KINDEL & ANDERSON 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LEZ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-14 |
| Decision Date | 1980-12-17 |