BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Spiro PD Personal Spirometer

    Reg #: 3007113169 · FEI: 3007113169 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sanbor Medical
    Registration Number
    3007113169
    FEI Number
    3007113169
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7584 Morris Court, Suite 218
    City
    Allentown
    State
    PA
    ZIP
    18106
    Country
    US

    Regulatory Submissions

    510(k) Number
    K103575

    Owner / Operator

    Firm Name
    Sanbor Medical
    Operator Number
    10028522
    Address
    7584 Morris Court, Suite 218
    City
    Allentown
    State
    PA
    Postal Code
    18106
    Country
    US
    Correspondent
    Wayne Meng

    Products

    Device Name Product Code
    Spirometer, Diagnostic BZG

    Proprietary Names

    Spiro PD Personal Spirometer

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)