BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    OSM-1 OXYGEN SATURATION MONITOR

    K Number: K853331 · Decision Jan 14, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    52
    Applicant Total
    22
    Review Days
    159

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    Basic Information

    Device Name
    OSM-1 OXYGEN SATURATION MONITOR
    K Number
    K853331
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2780
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Criticare Systems, Inc.
    Date Received
    August 8, 1985
    Decision Date
    January 14, 1986
    Product Code
    JOM
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

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