BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Basic Respitrace System

    Reg #: 2430863 · FEI: 2430863 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    AMBULATORY MONITORING, INC.
    Registration Number
    2430863
    FEI Number
    2430863
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    731 SAW MILL RIVER RD.
    City
    ARDSLEY
    State
    NY
    ZIP
    10502
    Country
    US

    Regulatory Submissions

    510(k) Number
    K772016

    Owner / Operator

    Firm Name
    AMBULATORY MONITORING, INC.
    Operator Number
    2430863
    Address
    731 SAW MILL RIVER RD., --
    City
    Ardsley
    State
    NY
    Postal Code
    10502
    Country
    US
    Correspondent
    THOMAS - KAZLAUSKY

    Products

    Device Name Product Code
    Spirometer, Monitoring (W/Wo Alarm) BZK

    Proprietary Names

    Basic Respitrace System

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility