BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ZOLL Manufacturing Corporation

    Reg #: 3008642652 · FEI: 3008642652 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    ZOLL Manufacturing Corporation
    Registration Number
    3008642652
    FEI Number
    3008642652
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    121 Gamma Dr
    City
    Pittsburgh
    State
    PA
    ZIP
    15238
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172510
    PMA Number
    P010030

    Owner / Operator

    Firm Name
    ZOLL Manufacturing Corporation
    Operator Number
    9045611
    Address
    121 GAMMA DRIVE, --
    City
    Pittsburgh
    State
    PA
    Postal Code
    15238
    Country
    US

    Products

    Device Name Product Code
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Plethysmograph, Impedance DSB
    Detector And Alarm, Arrhythmia DSI
    Electrocardiograph DPS
    Wearable Automated External Defibrillator MVK

    Proprietary Names

    uCor Heart Failure and Arrhythmia Management System ZOLL ECG Analysis Software ZOLL Arrhythmia Management System LifeVest Wearable Defibrillator

    Establishment Types

    Manufacture Medical Device