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

    HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM

    K Number: K893094 · Decision Oct 2, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    17
    Applicant Total
    4
    Review Days
    157

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    Basic Information

    Device Name
    HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM
    K Number
    K893094
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1750
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Heartware Intl. Corp.
    Date Received
    April 28, 1989
    Decision Date
    October 2, 1989
    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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    Other Clearances by Heartware Intl. Corp.

    K Number Device Name
    K932410 HEARTVIEW(R) CORONARY ANGIOGRAPH DIAGRAM/REPORT SY
    K933073 HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE
    K933058 HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW