BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Universal SmartECG

    Reg #: 3009443693 · FEI: 3009443693 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    VectraCor, Inc.
    Registration Number
    3009443693
    FEI Number
    3009443693
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    785 Totowa Rd Suite 100
    City
    Totowa
    State
    NJ
    ZIP
    07512
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173952

    Owner / Operator

    Firm Name
    VectraCor, Inc.
    Operator Number
    10038931
    Address
    785 Totowa Rod, Suite 100
    City
    Totowa
    State
    NJ
    Postal Code
    07512
    Country
    US
    Correspondent
    Brad S Schreck

    Products

    Device Name Product Code
    Electrocardiograph DPS
    Monitor, St Segment With Alarm MLD

    Proprietary Names

    Universal SmartECG

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198