The following data is part of a premarket notification filed by Resound Corp. with the FDA for Resound Digital 2000-bt W/digital 2000-df (digital Programmer).
| Device ID | K974257 |
| 510k Number | K974257 |
| Device Name: | RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) |
| Classification | Hearing Aid, Air Conduction |
| Applicant | RESOUND CORP. 2182 35TH AVE., CT. SUITE 1 Greeley, CO 80634 |
| Contact | Krista M Buckles |
| Correspondent | Krista M Buckles RESOUND CORP. 2182 35TH AVE., CT. SUITE 1 Greeley, CO 80634 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-13 |
| Decision Date | 1997-12-12 |
| Summary: | summary |