BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SCANNING COT

    K Number: K903901 · Decision Sep 21, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    11
    Applicant Total
    9
    Review Days
    29

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    Basic Information

    Device Name
    SCANNING COT
    K Number
    K903901
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1350
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Med-Tron Products, Inc.
    Date Received
    August 23, 1990
    Decision Date
    September 21, 1990
    Product Code
    IYZ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IYZ Bed, Scanning, Nuclear

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