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510(k) Data Aggregation

    K Number
    K010704
    Device Name
    DORNIR LC-1 CPAP SYSTEM
    Manufacturer
    Date Cleared
    2001-04-18

    (40 days)

    Product Code
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRYM MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K000888
    Device Name
    SANSIBAR CPAP SYSTEM
    Manufacturer
    Date Cleared
    2000-08-15

    (148 days)

    Product Code
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRYM MEDICAL LTD.

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

    Ask a specific question about this device

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