RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)— 510(k) K974257
Substantially EquivalentResound Corp.
FDA 510(k) clearance K974257 for RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER), Substantially Equivalent on 1997-12-12. Applicant: Resound Corp.. Device class: 1.
Clearance details
- Applicant
- Resound Corp.
- Product code
- Code ESD
- Device class
- Class 1
- Regulation
- 21 CFR 874.3300
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Greeley, CO, US
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