The following data is part of a premarket notification filed by Resound Corp. with the FDA for Resound Ed4 Personal Hearing System W/remote Control Option.
| Device ID | K971605 |
| 510k Number | K971605 |
| Device Name: | RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION |
| Classification | Hearing Aid, Air Conduction |
| Applicant | RESOUND CORP. 220 SAGINAW DRIVE, SEAPORT CENTRE Redwood City, CA 94063 |
| Contact | Krista M Buckles |
| Correspondent | Krista M Buckles 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 | 1997-05-01 |
| Decision Date | 1997-07-03 |
| Summary: | summary |