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510(k) Data Aggregation

    K Number
    K981725
    Device Name
    OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700
    Manufacturer
    Date Cleared
    1999-02-02

    (263 days)

    Product Code
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPTOVENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Optovent™ RR 9700 is intended as an adjunct to patient assessment and is used to continuously monitor the respiratory rate of adult patients. The device is intended to be used by qualified health care professionals trained in the use of the equipment. The device is not intended for home use.
    Device Description
    Not Found
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