BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Lifetech Cardio Model 8301 Temporary Pacemaker

    K Number: K182839 · Decision Feb 28, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    64
    Applicant Total
    2
    Review Days
    142

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Lifetech Cardio Model 8301 Temporary Pacemaker
    K Number
    K182839
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3600
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.
    Date Received
    October 9, 2018
    Decision Date
    February 28, 2019
    Product Code
    DTE
    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
    DTE Pulse-Generator, Pacemaker, External

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DTE), ordered by most recent decision date.

    Solo Pace Control

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Lifetech Cardio Temporary Pacemaker

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medtronic Model 5392 External Pulse Generator (EPG)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medtronic Model 5392 External Pulse Generator (EPG)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medtronic Model 5392 External Pulse Generator (EPG)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medtronic Model 53401 External Pulse Generator (EPG)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.

    K Number Device Name
    K232721 Lifetech Cardio Temporary Pacemaker