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510(k) Data Aggregation

    K Number
    K974848
    Device Name
    MINI-CISER
    Manufacturer
    HOUGEN MFG., INC.
    Date Cleared
    1998-08-06

    (220 days)

    Product Code
    BWF
    Regulation Number
    868.5690
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOUGEN MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Mini-Ciser is a Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT) in one device. The Mini-Ciser may be helpful in loosening and removal of mucus.
    Device Description
    The Mini-Ciser is a Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT) in one device.
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    K Number
    K974849
    Device Name
    X-AIR-CISER
    Manufacturer
    HOUGEN MFG., INC.
    Date Cleared
    1998-08-06

    (220 days)

    Product Code
    BYI
    Regulation Number
    868.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOUGEN MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The X-Air-Ciser is a Positive Expiratory Pressure (PEP) device, Inspiratory Muscle Trainer (IMT) and Percussor all in one device. The X-Air-Ciser can also function as a percussor, that may be helpful loosening and removing mucus.
    Device Description
    Not Found
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