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

    SREE MRI Transport Incubator

    K Number: K161918 · Decision Mar 3, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    24
    Applicant Total
    2
    Review Days
    233

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    Basic Information

    Device Name
    SREE MRI Transport Incubator
    K Number
    K161918
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5410
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Imaging Research Dba Sree Medical Systems
    Date Received
    July 13, 2016
    Decision Date
    March 3, 2017
    Product Code
    FPL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FPL Incubator, Neonatal Transport

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    Other Clearances by Advanced Imaging Research Dba Sree Medical Systems

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