CLEARTONE MODEL-1 & 2 HEARING AIDS— 510(k) K780459
Substantially EquivalentCleartone Custom Hearing Instruments
FDA 510(k) clearance K780459 for CLEARTONE MODEL-1 & 2 HEARING AIDS, Substantially Equivalent on 1978-03-30. Applicant: Cleartone Custom Hearing Instruments. Device class: 1.
Clearance details
- Applicant
- Cleartone Custom Hearing Instruments
- 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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