BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Breather Med

    Reg #: 3024987598 · FEI: 3024987598 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MCSC MEDICAL LLC
    Registration Number
    3024987598
    FEI Number
    3024987598
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    255 S Orange Ave Ste 104, Pmb 1085
    City
    Orlando
    State
    FL
    ZIP
    32801
    Country
    US

    Regulatory Submissions

    510(k) Number
    K944412

    Owner / Operator

    Firm Name
    MCSC Medical LLC
    Operator Number
    10086387
    Address
    255 S Orange Avenue, Suite 104 PMB 1085
    City
    Orlando
    State
    FL
    Postal Code
    32801
    Country
    US
    Correspondent
    Mark Carbone

    Products

    Device Name Product Code
    Spirometer, Therapeutic (Incentive) BWF

    Proprietary Names

    Breather Med

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility