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510(k) Data Aggregation

    K Number
    K971693
    Device Name
    RIONET HB-79P
    Manufacturer
    AUTHORIZED HEARING SYSTEMS, INC.
    Date Cleared
    1997-06-06

    (30 days)

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

    AUTHORIZED HEARING SYSTEMS, INC.

    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)): Serverity: 1. Slight 2. Mild X 3. Moderate X 4. Severe X 5. Profound Configuration: 1. High Frequency - Precipitously sloping X 2. Gradually Sloping X 3. Reverse Slope X 4. Flat 5. Other Other: 1. Low tolerance to loudness 2. 3. B. Specific Indications (Only if appropriate.): 1. psychoacoustic indications such as improved speech (Most intelligibility in background noise, must be supported by clinical data.) 2. 3.
    Device Description
    RION HB-79P
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    K Number
    K970057
    Device Name
    AHS OMEGA SP
    Manufacturer
    AUTHORIZED HEARING SYSTEMS, INC.
    Date Cleared
    1997-02-26

    (50 days)

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

    AUTHORIZED HEARING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963877
    Device Name
    AHS OMEGA CONCEPT
    Manufacturer
    AUTHORIZED HEARING SYSTEMS, INC.
    Date Cleared
    1996-12-06

    (71 days)

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

    AUTHORIZED HEARING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963878
    Device Name
    AHS OMEGA HF
    Manufacturer
    AUTHORIZED HEARING SYSTEMS, INC.
    Date Cleared
    1996-12-06

    (71 days)

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

    AUTHORIZED HEARING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963875
    Device Name
    AHS OMEGA K-AMP
    Manufacturer
    AUTHORIZED HEARING SYSTEMS, INC.
    Date Cleared
    1996-11-27

    (62 days)

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

    AUTHORIZED HEARING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963873
    Device Name
    AHS OMEGA DEQ
    Manufacturer
    AUTHORIZED HEARING SYSTEMS, INC.
    Date Cleared
    1996-11-26

    (61 days)

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

    AUTHORIZED HEARING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963874
    Device Name
    AHS OMEGA AGC
    Manufacturer
    AUTHORIZED HEARING SYSTEMS, INC.
    Date Cleared
    1996-11-26

    (61 days)

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

    AUTHORIZED HEARING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963876
    Device Name
    AHS OMEGA PP
    Manufacturer
    AUTHORIZED HEARING SYSTEMS, INC.
    Date Cleared
    1996-11-26

    (61 days)

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

    AUTHORIZED HEARING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963879
    Device Name
    AHS DELTA 22
    Manufacturer
    AUTHORIZED HEARING SYSTEMS, INC.
    Date Cleared
    1996-11-26

    (61 days)

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

    AUTHORIZED HEARING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963881
    Device Name
    AHS DELTA 22 T
    Manufacturer
    AUTHORIZED HEARING SYSTEMS, INC.
    Date Cleared
    1996-11-26

    (61 days)

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

    AUTHORIZED HEARING SYSTEMS, INC.

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

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