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510(k) Data Aggregation

    K Number
    K982723
    Device Name
    MAICO MA42
    Manufacturer
    BERNAFON-MAICO, INC.
    Date Cleared
    1998-10-28

    (84 days)

    Product Code
    EWO
    Regulation Number
    874.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    BERNAFON-MAICO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indication for use of the audiometer in this submission would be for the detection and diagnosis of a suspected hearing loss.
    Device Description
    Not Found
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    K Number
    K981142
    Device Name
    MAICO MA53
    Manufacturer
    BERNAFON-MAICO, INC.
    Date Cleared
    1998-04-22

    (23 days)

    Product Code
    EWO
    Regulation Number
    874.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    BERNAFON-MAICO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indications for use of the audiometer in this submission would be for the detection and diagnosis of a suspected hearing loss.
    Device Description
    Not Found
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    K Number
    K974069
    Device Name
    OPUS 2 - CANAL SERIES (ITC)
    Manufacturer
    BERNAFON-MAICO, INC.
    Date Cleared
    1997-12-15

    (48 days)

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

    BERNAFON-MAICO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A. General Indications: The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories: Severity: 1. Slight X 2. Mild X 3. Moderate X 4. Severe 5. Profound Configuration: 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping 3. Reverse Slope X 4. Flat 5. Other Other: X 1. Low Tolerance To Loudness 2. 3.
    Device Description
    OPUS 2 - CANAL SERIES ( ITC )
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    K Number
    K974152
    Device Name
    OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)
    Manufacturer
    BERNAFON-MAICO, INC.
    Date Cleared
    1997-12-15

    (41 days)

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

    BERNAFON-MAICO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A. General Indications: The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories: Severity: X 1. Slight X 2. Mild 3. Moderate 4. Severe 5. Profound Configuration: 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping 3. Reverse Slope X 4. Flat 5. Other Other: 1. Low Tolerance To Loudness 2. 3.
    Device Description
    OPUS 2 - COMPLETELY - IN - CANAL SERIES ( CIC ) Device Name:
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    K Number
    K974211
    Device Name
    OPUS 2 - FULL CONCHA SERIES - ITE
    Manufacturer
    BERNAFON-MAICO, INC.
    Date Cleared
    1997-12-15

    (35 days)

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

    BERNAFON-MAICO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - A. General Indications: The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories: | Severity: | Configuration: | Other: | |-----------------|--------------------------------------------------|-----------------------------------| | ___ 1. Slight | ___ 1. High Frequency<br>- Precipitously Sloping | X 1. Low Tolerance<br>To Loudness | | X 2. Mild | X 2. Gradually Sloping | 2. ___ | | X 3. Moderate | ___ 3. Reverse Slope | 3. ___ | | X 4. Severe | X 4. Flat | | | ___ 5. Profound | ___ 5. Other | |
    Device Description
    Not Found
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    K Number
    K973948
    Device Name
    DUALINE 100 BTE
    Manufacturer
    BERNAFON-MAICO, INC.
    Date Cleared
    1997-10-28

    (12 days)

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

    BERNAFON-MAICO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A. General Indications: The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories: 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 X 3. Reverse Slope X 4. Flat 5. Other Other: X 1. Low Tolerance To Loudness 2. 3.
    Device Description
    DUALINE 100 BTE
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    K Number
    K971158
    Device Name
    DUALINE 400 CIC
    Manufacturer
    BERNAFON-MAICO, INC.
    Date Cleared
    1997-06-13

    (77 days)

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

    BERNAFON-MAICO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories: Severity: 1. Slight, X 2. Mild, X 3. Moderate, 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.
    Device Description
    DUALINE 400 CIC
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    K Number
    K971080
    Device Name
    MAICO MA52
    Manufacturer
    BERNAFON-MAICO, INC.
    Date Cleared
    1997-06-06

    (73 days)

    Product Code
    EWO
    Regulation Number
    874.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    BERNAFON-MAICO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indications for use of the audiometer in this submission would be for the detection and diagnosis of a suspected hearing loss.
    Device Description
    Not Found
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    K Number
    K962275
    Device Name
    MAICO MA25 SERIES II WITH SPEECH
    Manufacturer
    BERNAFON-MAICO, INC.
    Date Cleared
    1996-09-05

    (84 days)

    Product Code
    EWO
    Regulation Number
    874.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    BERNAFON-MAICO, INC.

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

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