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

    PARI HYDRATE G

    K Number: K070107 · Decision Feb 23, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    10
    Review Days
    43

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    Basic Information

    Device Name
    PARI HYDRATE G
    K Number
    K070107
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pari Innovative Manufacturers, Inc.
    Date Received
    January 11, 2007
    Decision Date
    February 23, 2007
    Product Code
    BTT
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    Y

    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 Pari Innovative Manufacturers, Inc.

    K Number Device Name
    K072670 MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER
    K072982 PARI HYDRATE V
    K070498 HYPER SAL
    K062158 LC SPRINT STAR
    K061381 LC STAR WITH NASAL ADAPTER
    K060357 TREK S NEBULIZER COMPRESSOR
    K060399 LC SPRINT NEBULIZER
    K033833 EFLOW ELECTRONIC INHALER/NEBULIZER
    K020944 VORTEX VALVED HOLDING CHAMBER