The following data is part of a premarket notification filed by Resound Corp. with the FDA for Resound Personal Hearing System Soundlink-1.
| Device ID | K922570 |
| 510k Number | K922570 |
| Device Name: | RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1 |
| Classification | Hearing Aid, Group And Auditory Trainer |
| Applicant | RESOUND CORP. 220 SAGINAW DRIVE, SEAPORT CENTRE Redwood City, CA 94063 |
| Contact | Jeannette S Johnson |
| Correspondent | Jeannette S Johnson RESOUND CORP. 220 SAGINAW DRIVE, SEAPORT CENTRE Redwood City, CA 94063 |
| Product Code | EPF |
| CFR Regulation Number | 874.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-01 |
| Decision Date | 1992-08-06 |