The following data is part of a premarket notification filed by Rion Co. Ltd. Dba Rion Acoustic Device with the FDA for Rionet Hearing Aid Hb-52as.
| Device ID | K915319 |
| 510k Number | K915319 |
| Device Name: | RIONET HEARING AID HB-52AS |
| Classification | Hearing Aid, Air Conduction |
| Applicant | RION CO. LTD. DBA RION ACOUSTIC DEVICE C/O AUTHORIZED HEARING SYSTEMS 806 BEAVER STREET Bristol, PA 19007 |
| Contact | Eileen Anderson |
| Correspondent | Eileen Anderson RION CO. LTD. DBA RION ACOUSTIC DEVICE C/O AUTHORIZED HEARING SYSTEMS 806 BEAVER STREET Bristol, PA 19007 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-22 |
| Decision Date | 1992-01-09 |