BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Premier Heart, LLC

    Reg #: 2438852 · FEI: 3003289183 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    2

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    Registration Details

    Registration Name
    Premier Heart, LLC
    Registration Number
    2438852
    FEI Number
    3003289183
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    110 Main St, Suites 201-88
    City
    Port Washington
    State
    NY
    ZIP
    11050
    Country
    US

    Regulatory Submissions

    510(k) Number
    K992703

    Owner / Operator

    Firm Name
    Premier Heart, LLC
    Operator Number
    10023470
    Address
    110 Main Street, Suite 201-88
    City
    Port Washington
    State
    NY
    Postal Code
    11050
    Country
    US
    Correspondent
    Joseph T Shen, MD

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK
    Electrode, Electrocardiograph DRX

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility