BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MODEL 220 PATIENT MAGNET

    K Number: K092364 · Decision Nov 3, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    90

    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
    MODEL 220 PATIENT MAGNET
    K Number
    K092364
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.3690
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cyberonics, Inc.
    Date Received
    August 5, 2009
    Decision Date
    November 3, 2009
    Product Code
    DTG
    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
    DTG Magnet, Test, Pacemaker

    Similar 510(k) Clearances

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

    MAGNO ALARM

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    MAESTRO PACEMAKER TEST MAGNET

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    IMPLANTABLE ENDOCARDIAL PACING LEADS

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    TEST MAGNET

    FDA 510(k)
    FDA Class 1 ·Cardiovascular
    View all