The following data is part of a premarket notification filed by Resound Corp. with the FDA for Resound(r) Personal Hearing System Ed-3 Encore.
| Device ID | K950319 |
| 510k Number | K950319 |
| Device Name: | RESOUND(R) PERSONAL HEARING SYSTEM ED-3 ENCORE |
| Classification | Hearing Aid, Air Conduction |
| Applicant | RESOUND CORP. 220 SAGINAW DRIVE, SEAPORT CENTRE Redwood City, CA 94063 |
| Contact | Krista M Buckles |
| Correspondent | Krista M Buckles RESOUND CORP. 220 SAGINAW DRIVE, SEAPORT CENTRE Redwood City, CA 94063 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-26 |
| Decision Date | 1995-02-08 |