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510(k) Data Aggregation

    K Number
    K972818
    Device Name
    D72 DIGITAL
    Date Cleared
    1997-10-17

    (80 days)

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

    PHILIPS HEARING INSTRUMENTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A. General Indications: The indication for use of the air conduction hearing aids in this submission is to amplify some indicated for individuals with impaired hearing. The devices are indicated for individuals with losses in hearing. The devices are indicated for individuals with losses in hearing. The devices are indicated as and can and Severity: X 1. Slight X 2. Mild X 3. Moderate X 4. Severe 5. Profound Configuration: X 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping X 3. Reverse Slope X 4. Flat 5. Other 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
    Not Found
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    K Number
    K971804
    Device Name
    PHILIPS S1694, S1695
    Date Cleared
    1997-06-06

    (23 days)

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

    PHILIPS HEARING INSTRUMENTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A. General Indications: The indication for use of the air conduction hearing aids in this The indication for use of the individuals with impaired The devices are indicated for individuals with losses in hearing. nearing. The devices are indicated appropriate space(s)): Severity: 2. Mild, Configuration: 1. High Frequency - Precipitously Sloping, 3. Reverse Slope, 5. Other, Other: 1. Low tolerance To Loudness, 2., 3. B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech (Most psychoacouscic Indications back as supported by clinical data.) 1., 2., 3.
    Device Description
    Not Found
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    K Number
    K965088
    Device Name
    M11 SERIES: M11, M11M
    Date Cleared
    1997-01-24

    (36 days)

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

    PHILIPS HEARING INSTRUMENTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K961770
    Device Name
    PHILIPS 71 SERIES
    Date Cleared
    1996-08-02

    (86 days)

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

    PHILIPS HEARING INSTRUMENTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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