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

    POS T-7000

    K Number: K981805 · Decision Aug 7, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    78

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    Basic Information

    Device Name
    POS T-7000
    K Number
    K981805
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1570
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pos Technologies, Inc.
    Date Received
    May 21, 1998
    Decision Date
    August 7, 1998
    Product Code
    HCS
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HCS Device, Temperature Measurement, Direct Contact, Powered

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