The following data is part of a premarket notification filed by Rion Acoustic Instruments, Inc. with the FDA for Rionet Hearing Aid Hi-06.
| Device ID | K853636 |
| 510k Number | K853636 |
| Device Name: | RIONET HEARING AID HI-06 |
| Classification | Hearing Aid, Air Conduction |
| Applicant | RION ACOUSTIC INSTRUMENTS, INC. 555 SOUTH FLOWER ST. 26TH. FLOOR Los Angeles, CA 90017 |
| Contact | Richard G Wallace |
| Correspondent | Richard G Wallace RION ACOUSTIC INSTRUMENTS, INC. 555 SOUTH FLOWER ST. 26TH. FLOOR Los Angeles, CA 90017 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-30 |
| Decision Date | 1985-09-23 |