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

    Bloom2 Programmable Electrophysiology Stimulator

    K Number: K173439 · Decision Mar 29, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    146

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    Basic Information

    Device Name
    Bloom2 Programmable Electrophysiology Stimulator
    K Number
    K173439
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1750
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fischer Medical
    Date Received
    November 3, 2017
    Decision Date
    March 29, 2018
    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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