The following data is part of a premarket notification filed by Resound Corp. with the FDA for Digital Lgob Procedure Using Resound, Digital 5000 Series Hearing Aids.
| Device ID | K984547 |
| 510k Number | K984547 |
| Device Name: | DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS |
| Classification | Audiometer |
| Applicant | RESOUND CORP. 220 SAGINAW DRIVE, SEAPORT CENTRE Redwood City, CA 94063 |
| Contact | Gary Roesel |
| Correspondent | Gary Roesel RESOUND CORP. 220 SAGINAW DRIVE, SEAPORT CENTRE Redwood City, CA 94063 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-22 |
| Decision Date | 1999-03-19 |
| Summary: | summary |