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

    POLY-TAC

    K Number: K882235 · Decision Oct 5, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    165
    Applicant Total
    1
    Review Days
    131

    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
    POLY-TAC
    K Number
    K882235
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cardiovascular Group, Inc.
    Date Received
    May 27, 1988
    Decision Date
    October 5, 1988
    Product Code
    LDD
    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
    LDD Dc-Defibrillator, Low-Energy, (Including Paddles)

    Similar 510(k) Clearances

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

    Switched Internal Paddles

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tempus LS - Manual

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Rapid Hair Removal Pads

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZOLL E SERIES ALS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARDIOMED

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