BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Rhythimia HDx 6m CardioLab Direct Connect ECG

    Reg #: 3007029079 · FEI: 3007029079 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AMPHENOL ALDEN PRODUCTS COMPANY
    Registration Number
    3007029079
    FEI Number
    3007029079
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Parque Industrial Dynatech, Ave. Severiano Talamante No. 6-B
    City
    Hermosillo Sonora
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K162793

    Owner / Operator

    Firm Name
    Amphenol Alden Products Company
    Operator Number
    10025614
    Address
    117 N Main Street
    City
    Brockton
    State
    MA
    Postal Code
    02301
    Country
    US
    Correspondent
    Michael Virusso

    US Agent

    Business Name
    AMPHENOL ALDEN PRODUCTS
    Contact Name
    Michael Virusso
    Address
    117 N. Main Street
    City
    Brockton
    State
    MA
    ZIP
    02301
    Country
    US
    Email
    [email protected]
    Phone
    508 4277000 ext. 7010

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    Rhythimia HDx 6m CardioLab Direct Connect ECG Rhythmia HDX 3m CardioLab Direct Connect IC Rhytmia HDx 3m Clearsign Direct Connect ECG Rhythmia HDx Patch Cable Rhymia HDx 6m Clearsign Direct Connect ECG Rhythmia HDx 3m CardioLab Direct Connect ECG EGM Out to Signal Station Cable -IBI Rhythmia HDx 3m Clearsign Direct Connect IC A/B EGM Out to SIgnal Station Cable -Stockert Rhythmia HDx Breakout Box Cable Rhythmia HDx 6m Clearsign Direct Connect Orion Rhythmia HDx 6m Clearsign Direct Connect IC A/B Rhythmia HDx 6m CardioLab Direct Connect IC Rhytmia HDx 3m Clearsign Direct Connect Orion

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)