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

    CONSTANT CURRENT STIMULATOR MODEL 022101

    K Number: K900553 · Decision Mar 13, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    17
    Applicant Total
    15
    Review Days
    35

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    Basic Information

    Device Name
    CONSTANT CURRENT STIMULATOR MODEL 022101
    K Number
    K900553
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1750
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Ep Technologies, Inc.
    Date Received
    February 6, 1990
    Decision Date
    March 13, 1990
    Product Code
    JOQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

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