The following data is part of a premarket notification filed by Resound Corp. with the FDA for Audiometer Digital Hearing System.
| Device ID | K884044 |
| 510k Number | K884044 |
| Device Name: | AUDIOMETER DIGITAL HEARING SYSTEM |
| Classification | Audiometer |
| 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 | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-26 |
| Decision Date | 1989-02-22 |