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510(k) Data Aggregation
K Number
K973846Device Name
AIR CONDUCTION HEARING AID
Manufacturer
Date Cleared
1997-10-29
(21 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
BARON TRADING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A. General: The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following catage(fes). (Check appropriate space(s)): Severity: Mild, Moderate. Configuration: Flat.
B. Specific (List Claims): Not Found
Device Description
AIR CONDUCTION HEARING AID (BC-H2000)
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