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

    HVT 2.0

    K Number: K221318 · Decision Dec 13, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    2
    Applicant Total
    13
    Review Days
    221

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    Basic Information

    Device Name
    HVT 2.0
    K Number
    K221318
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5454
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vapotherm, Inc.
    Date Received
    May 6, 2022
    Decision Date
    December 13, 2022
    Product Code
    QAV
    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
    QAV High Flow/High Velocity Humidified Oxygen Delivery Device

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    Other Clearances by Vapotherm, Inc.

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    DEN170001 Precision Flow® HVNI
    K111640 PRECISION FLOW(R) - HELIOX
    K103316 FLOWREST
    K072845 PRECISION FLOW
    K070056 VAPOTHERM MODEL# 2000I AND 2000H
    K042245 VAPOTHERM MODEL#2000I, 200H
    Search all 13 clearances from Vapotherm, Inc. →