BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ADULT Sotair Device

    Reg #: 3024753104 · FEI: 3024753104 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SAFEBVM CORP
    Registration Number
    3024753104
    FEI Number
    3024753104
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    50 Milk Street, 16th Floor
    City
    Boston
    State
    MA
    ZIP
    02109
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212905

    Owner / Operator

    Firm Name
    SafeBVM Corp
    Operator Number
    10086129
    Address
    50 Milk Street, 16th Floor
    City
    Boston
    State
    MA
    Postal Code
    02109
    Country
    US
    Correspondent
    Haris Shekhani

    Products

    Device Name Product Code
    Ventilator, Emergency, Manual (Resuscitator) BTM

    Proprietary Names

    ADULT Sotair Device

    Establishment Types

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