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510(k) Data Aggregation

    K Number
    K970371
    Device Name
    FLOTEC OXYSAVRR (S)
    Manufacturer
    FLOTEC, INC.
    Date Cleared
    1997-07-10

    (160 days)

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

    FLOTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    THERE ARE NO INDICATIONS FOR USE OF THIS DEVICE BY ITSELF. THE DEVICE IS AN ORTIONAL COMPONENT OF THE OXYGEN DELI'VERY SYSTEM PRESCRIBED FOR USE USE PARTIENTS , SUFFERING FROM THE SOLE PURPOSE OF SYSTEM PRESCRIVED PULMONARY DISEASE. CHRONIC OBSTRUCTIVE PULMONARY DISENSE. THIS DEVICE IS TO CONSERVE OXYGEN BY STOPEN BY STOPPING THE FIOW WHEN THIS DEVICE IS TO CONSERVE OXYGEN BY STOPEN EXHALATION AND THE PATIENT IS EXHALING OR PAUSING BETWEEN EXHALATION AND . IS EXHALTIAC OK FRONING DEVICE SEMSES THE BECIMMING I NHAL ING. OF INHALATION BY THE USER.
    Device Description
    OXYGEN CONSERVER (VENTILATOR - NON CONTINUOUS)
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