The following data is part of a premarket notification filed by Resound Corp. with the FDA for Resound Demo. Behind-the-ear Hrng., Model Demo Bte.
| Device ID | K894019 |
| 510k Number | K894019 |
| Device Name: | RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE |
| Classification | Hearing Aid, Master |
| Applicant | RESOUND CORP. 220 SAGINAW DRIVE, SEAPORT CENTRE Redwood City, CA 94063 |
| Contact | Vincent Pluvinage |
| Correspondent | Vincent Pluvinage RESOUND CORP. 220 SAGINAW DRIVE, SEAPORT CENTRE Redwood City, CA 94063 |
| Product Code | KHL |
| CFR Regulation Number | 874.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-06 |
| Decision Date | 1989-09-21 |