LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K974129
    Device Name
    HI-69E, HI-69N, HI-69P
    Manufacturer
    ROCKWIN CORP.
    Date Cleared
    1997-12-12

    (39 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROCKWIN CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    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 category(ies). (Check appropriate space(s)): Severity: _ 1. Light _ 2. Mild X 3. Moderate _ 4. Severe _ 5. Profound Configuration: _ 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping _ 3. Reverse Slope _ 4. Flat _ 5. Other Other _ 1. Low tolerance To Loudness _ 2. _ 3.
    Device Description
    HI-68E, HI-69N and HI-69P are air conduction hearing aids.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1