The following data is part of a premarket notification filed by Rion Acoustic Instruments, Inc. with the FDA for Rionet Hearing Aid Hb-35.
| Device ID | K842875 |
| 510k Number | K842875 |
| Device Name: | RIONET HEARING AID HB-35 |
| Classification | Hearing Aid, Air Conduction |
| Applicant | RION ACOUSTIC INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-23 |
| Decision Date | 1984-08-24 |