BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Pivot Breath Sensor

    Reg #: 3014023337 · FEI: 3014023337 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Pivot Health Technologies Inc
    Registration Number
    3014023337
    FEI Number
    3014023337
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1010 Commercial Street, Suite C
    City
    San Carlos
    State
    CA
    ZIP
    94070
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171408

    Owner / Operator

    Firm Name
    Pivot Health Technologies Inc.
    Operator Number
    10055866
    Address
    1010 Commercial Street, Suite C
    City
    San Carlos
    State
    CA
    Postal Code
    94070
    Country
    US
    Correspondent
    Daniel J Balbierz

    Products

    Device Name Product Code
    Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase CCJ

    Proprietary Names

    Pivot Breath Sensor

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility