BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PPM3

    Reg #: 3003294644 · FEI: 3003294644 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ZOE MEDICAL, INC.
    Registration Number
    3003294644
    FEI Number
    3003294644
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    460 BOSTON ST.
    City
    TOPSFIELD
    State
    MA
    ZIP
    01983
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130740

    Owner / Operator

    Firm Name
    Zoe Medical, Inc
    Operator Number
    9041242
    Address
    460 BOSTON ST., --
    City
    Topsfield
    State
    MA
    Postal Code
    01983
    Country
    US
    Correspondent
    Stephen J Staats

    Products

    Device Name Product Code
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI

    Proprietary Names

    PPM3 Nightingale PPM3 Nightingale MPC Nightingale Monitoring System

    Establishment Types

    Manufacture Medical Device