HEARING AID CUSTOM ITE— 510(k) K813206
Substantially EquivalentDuvan Acoustics, Inc.
FDA 510(k) clearance K813206 for HEARING AID CUSTOM ITE, Substantially Equivalent on 1981-12-08. Applicant: Duvan Acoustics, Inc.. Device class: 1.
Clearance details
- Applicant
- Duvan Acoustics, Inc.
- 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
- Mchenry, IL, US
Recent devices under product code ESD
view allData sourced from openFDA. This site is unofficial and independent of the FDA.