The following data is part of a premarket notification filed by Rion Acoustic Instruments, Inc. with the FDA for Rionet Hearing Aid.
| Device ID | K861728 |
| 510k Number | K861728 |
| Device Name: | RIONET HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | RION ACOUSTIC INSTRUMENTS, INC. 912 W. 223RD ST. Torrance, CA 90502 |
| Contact | Masatsugu Otsuka |
| Correspondent | Masatsugu Otsuka RION ACOUSTIC INSTRUMENTS, INC. 912 W. 223RD ST. Torrance, CA 90502 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-06 |
| Decision Date | 1986-05-27 |