BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    PEDIATRIC DEFIB K-PADS

    K Number: K935083 · Decision Jul 25, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    165
    Applicant Total
    26
    Review Days
    273

    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
    PEDIATRIC DEFIB K-PADS
    K Number
    K935083
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    Katecho, Inc.
    Date Received
    October 25, 1993
    Decision Date
    July 25, 1994
    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 Katecho, Inc.

    K Number Device Name
    K012404 K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
    K010543 KM-30 TENS ELECTRODE
    K003228 K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A
    K002806 K-DEFIB/PACE, MODEL KDP-60A
    K000870 KM-10 TENS ELECTRODE
    K993745 K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80
    K991007 K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60
    K981737 K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60
    K954504 K-DEFIB/PACE PEDIATRIC ELECTRODE
    K934692 K-DEFIB/PACE PEDIATRIC ELECTRODE
    Search all 26 clearances from Katecho, Inc. →