The following data is part of a premarket notification filed by Resound Corp. with the FDA for System Bt W/remote Control Option Hearing Aid.
| Device ID | K912665 |
| 510k Number | K912665 |
| Device Name: | SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | RESOUND CORP. 220 SAGINAW DRIVE, SEAPORT CENTRE Redwood City, CA 94063 |
| Contact | Jeannette Johnson |
| Correspondent | Jeannette Johnson 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 | 1991-06-18 |
| Decision Date | 1991-07-24 |