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

    MEGAPULSE II

    K Number: K973732 · Decision Jan 23, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    44
    Applicant Total
    1
    Review Days
    115

    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
    MEGAPULSE II
    K Number
    K973732
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5290
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pti
    Date Received
    September 30, 1997
    Decision Date
    January 23, 1998
    Product Code
    IMJ
    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
    IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

    Similar 510(k) Clearances

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

    BTL-899TT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ViVY

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Curapuls 670

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Reprieve by RegenesisTM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BTL-703

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ViaTherm BOOST

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