BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Zio Monitor

    Reg #: 3014929383 · FEI: 3014929383 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CAL-COMP USA
    Registration Number
    3014929383
    FEI Number
    3014929383
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1940 Camino Vida Roble
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202359

    Owner / Operator

    Firm Name
    Cal-Comp USA
    Operator Number
    10077728
    Address
    1940 Camino Vida Roble
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US
    Correspondent
    Tammy DeBenedetto

    Products

    Device Name Product Code
    Recorder, Magnetic Tape, Medical DSH

    Proprietary Names

    Zio Monitor

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)