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

    DP-700 NIKMAN DEFIB-PADS

    K Number: K872793 · Decision Oct 9, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    165
    Applicant Total
    15
    Review Days
    87

    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
    DP-700 NIKMAN DEFIB-PADS
    K Number
    K872793
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Nikomed U.S.A., Inc.
    Date Received
    July 14, 1987
    Decision Date
    October 9, 1987
    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

    Other Clearances by Nikomed U.S.A., Inc.

    K Number Device Name
    K022909 NIKOMED TRACE 1 ECG ELECTRODES
    K000079 NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M
    K950473 DISPOSABLE ECG MONITORING ELECTRODE
    K950475 DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540
    K950472 DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM
    K950471 DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM
    K950477 DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM
    K950470 DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM
    K950474 DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM
    K950478 DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MM
    Search all 15 clearances from Nikomed U.S.A., Inc. →