BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SHAPE MEDICAL SYSTEMS, INC

    Reg #: 3008072932 · FEI: 3008072932 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHAPE MEDICAL SYSTEMS, INC
    Registration Number
    3008072932
    FEI Number
    3008072932
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    MedTech Center/Shape Medical Systems, In, 5000 Township Parkway
    City
    Saint Paul
    State
    MN
    ZIP
    55110
    Country
    US

    Regulatory Submissions

    510(k) Number
    K150888

    Owner / Operator

    Firm Name
    Shape Medical Systems, Inc
    Operator Number
    10029892
    Address
    MedTech Center/Shape Medical Systems, In, 5000 Township Parkway
    City
    Saint Paul
    State
    MN
    Postal Code
    55110
    Country
    US
    Correspondent
    Brant Newman

    Products

    Device Name Product Code
    Calculator, Predicted Values, Pulmonary Function BTY

    Proprietary Names

    Shape-HF DRR Testing system SHAPE-HF

    Establishment Types

    Manufacture Medical Device