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

    RT-200 COMPUTER INTERFACE

    K Number: K875075 · Decision Apr 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    9
    Applicant Total
    29
    Review Days
    134

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    Basic Information

    Device Name
    RT-200 COMPUTER INTERFACE
    K Number
    K875075
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.2620
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Timeter Instrument Corp.
    Date Received
    December 9, 1987
    Decision Date
    April 21, 1988
    Product Code
    BXX
    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
    BXX Calibrator, Pressure, Gas

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