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

    SIEMENS SC9000/SC9015 TCP02/C02 MODULE

    K Number: K980287 · Decision Aug 12, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    46
    Applicant Total
    781
    Review Days
    198

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    Basic Information

    Device Name
    SIEMENS SC9000/SC9015 TCP02/C02 MODULE
    K Number
    K980287
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2500
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Medical Solutions USA, Inc.
    Date Received
    January 26, 1998
    Decision Date
    August 12, 1998
    Product Code
    KLK
    Advisory Committee
    Anesthesiology
    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
    KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

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