BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    DISPOSABLE SPO2 SENSOR M1134A

    K Number: K091572 · Decision Sep 22, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    25
    Review Days
    112

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    Basic Information

    Device Name
    DISPOSABLE SPO2 SENSOR M1134A
    K Number
    K091572
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
    Date Received
    June 2, 2009
    Decision Date
    September 22, 2009
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DQA Oximeter

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    Other Clearances by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN

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