CUSTOM IN-THE-EAR HEARING AID— 510(k) K811719
Substantially EquivalentHearing Health Group, Inc.
FDA 510(k) clearance K811719 for CUSTOM IN-THE-EAR HEARING AID, Substantially Equivalent on 1981-07-27. Applicant: Hearing Health Group, Inc.. Device class: 1.
Clearance details
- Applicant
- Hearing Health Group, 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
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