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

    PRECISION FLOW

    K Number: K072845 · Decision Jul 17, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    13
    Review Days
    287

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    Basic Information

    Device Name
    PRECISION FLOW
    K Number
    K072845
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vapotherm, Inc.
    Date Received
    October 4, 2007
    Decision Date
    July 17, 2008
    Product Code
    BTT
    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
    BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

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    Other Clearances by Vapotherm, Inc.

    K Number Device Name
    K254078 HVT 2.0
    K221318 HVT 2.0
    K220869 Vapotherm Aerosol Adapter AAA-2
    K203357 HVT 2.0
    K191010 Palladium High Flow Therapy System
    DEN170001 Precision Flow® HVNI
    K111640 PRECISION FLOW(R) - HELIOX
    K103316 FLOWREST
    K070056 VAPOTHERM MODEL# 2000I AND 2000H
    K042245 VAPOTHERM MODEL#2000I, 200H
    Search all 13 clearances from Vapotherm, Inc. →