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

    ZOLL PROPAQ MD

    K Number: K102468 · Decision Sep 30, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    165
    Applicant Total
    21
    Review Days
    31

    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
    ZOLL PROPAQ MD
    K Number
    K102468
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zoll Medical Corporation, World Wide Headquarters
    Date Received
    August 30, 2010
    Decision Date
    September 30, 2010
    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 Zoll Medical Corporation, World Wide Headquarters

    K Number Device Name
    K133239 ZOLL E SERIES
    K133269 ZOLL X SERIES
    K120406 ZOLL FULLY AUTOMATIC AED PLUS
    K120907 ZOLL R SERIES
    K112761 ZOLL PROPAQ MD
    K112432 ZOLL X SERIES
    K111296 ZOLL RESCUENETLINK
    K111594 ZOLL E SERIES
    K110361 ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
    K110154 ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
    Search all 21 clearances from Zoll Medical Corporation, World Wide Headquarters →