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

    Macroduct Advanced Model 3710

    K Number: K180627 · Decision Jul 27, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    140

    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
    Macroduct Advanced Model 3710
    K Number
    K180627
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5525
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Elitechgroup, Inc.
    Date Received
    March 9, 2018
    Decision Date
    July 27, 2018
    Product Code
    KTB
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KTB Device, Iontophoresis, Specific Uses

    Similar 510(k) Clearances

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

    RH-950

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    RH-900

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TRANSQ3

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PHORESOR MODEL PM2000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all