FDA Registration Active 🇺🇸 United States

All-Day Clear Slim ADCS1 Hearing Aid

Reg #: 3008848788 · FEI: 3008848788 · Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Sonova USA Inc.
Registration Number
3008848788
FEI Number
3008848788
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
444 Commerce Street
City
Aurora
State
IL
ZIP
60504
Country
US

Regulatory Submissions

510(k) Number
K230538

Owner / Operator

Firm Name
Sonova AG
Operator Number
9028479
Address
Laubisruetistrasse 28
City
Staefa
State
Zurich
Postal Code
8712
Country
CH

Products

Device Name Product Code
Self-Fitting Air-Conduction Hearing Aid, Over The Counter QUH

Proprietary Names

All-Day Clear Slim ADCS1 Hearing Aid All-Day Clear ADC1 Hearing Aid

Establishment Types

Complaint File Establishment per 21 CFR 820.198