BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Breathe+

    K Number: K222018 · Decision Jun 2, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    107
    Applicant Total
    1
    Review Days
    329

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    Basic Information

    Device Name
    Breathe+
    K Number
    K222018
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5690
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Peep Medical, LLC Dba Go2 Devices
    Date Received
    July 8, 2022
    Decision Date
    June 2, 2023
    Product Code
    BWF
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BWF Spirometer, Therapeutic (Incentive)

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