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

    LC SPRINT STAR

    K Number: K062158 · Decision Aug 28, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    10
    Review Days
    31

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    Basic Information

    Device Name
    LC SPRINT STAR
    K Number
    K062158
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pari Innovative Manufacturers, Inc.
    Date Received
    July 28, 2006
    Decision Date
    August 28, 2006
    Product Code
    CAF
    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
    CAF Nebulizer (Direct Patient Interface)

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    Other Clearances by Pari Innovative Manufacturers, Inc.

    K Number Device Name
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    K070498 HYPER SAL
    K070107 PARI HYDRATE G
    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