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-53w.
| Device ID | K931320 |
| 510k Number | K931320 |
| Device Name: | RIONET HEARING AID HB-53W |
| 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 | Henry C Smith |
| Correspondent | Henry C Smith 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 | 1993-03-16 |
| Decision Date | 1993-05-05 |