BEUDAMED
    FDA Registration Inactive 🇺🇸 United States

    PNEUMA THERAPEUTICS, INC.

    · Expires 2026
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    PNEUMA THERAPEUTICS, INC.
    Status
    Inactive
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1253 Holmgrove Dr
    City
    San Marcos
    State
    CA
    ZIP
    92078
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210112

    Owner / Operator

    Firm Name
    Pneuma Therapeutics, Inc.
    Operator Number
    10095797
    Address
    1253 Holmgrove Dr
    City
    San Marcos
    State
    CA
    Postal Code
    92078
    Country
    US
    Correspondent
    Marc Flaim

    Products

    Device Name Product Code
    Mask, Gas, Anesthetic BSJ
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK

    Proprietary Names

    XChange™ Oxygen Therapy Positive Pressure Interface with Integrated End Tidal CO2 Sampling

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility