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510(k) Data Aggregation

    K Number
    K974242
    Device Name
    ARGOSY PROGRAMMABLE ONQUE
    Manufacturer
    ARGOSY ELECTRONICS
    Date Cleared
    1998-01-20

    (69 days)

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

    ARGOSY ELECTRONICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A. General Indications: 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: 2. Mild X, 3. Moderate X, 4. Severe X. Configuration: 1. High Frequency - Precipitously Sloping X, 2. Gradually Sloping X, 4. Flat X, 5. Other: steeply sloping X. Other: 1. Low Tolerance to Loudness X.
    Device Description
    Programmable OnQue for HS, CCA, and CAMEO Models
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    K Number
    K971699
    Device Name
    ARGOSY DYNAMEQ
    Manufacturer
    ARGOSY ELECTRONICS
    Date Cleared
    1997-07-03

    (56 days)

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

    ARGOSY ELECTRONICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A. General Indications: 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. Slight X 2. Mild X 3. Moderate X 4. Severe 5. Profound Configuration: X 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping 3. Reverse Slope X 4. Flat X 5. Other Steeply sloping Other X 1. Low tolerance To Loudness 2. 3. B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) 1. 2. 3.
    Device Description
    Argosy Dynameq Series Models: HS, CCA,Cameo, Passport, Passport Deluxe, Shado, Eclipse, CCAS, CCAS Deluxe, and CCA-Mini Canal
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    K Number
    K961729
    Device Name
    ARGOSY PROGRAMMABLE
    Manufacturer
    ARGOSY ELECTRONICS
    Date Cleared
    1996-05-29

    (26 days)

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

    ARGOSY ELECTRONICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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