BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    Rapid Aid Instant Disposable Infant Heel Warmer

    K Number: K150627 · Decision May 27, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    77

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    Basic Information

    Device Name
    Rapid Aid Instant Disposable Infant Heel Warmer
    K Number
    K150627
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    890.5710
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rapid Aid Corp.
    Date Received
    March 11, 2015
    Decision Date
    May 27, 2015
    Product Code
    MPO
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MPO Infant Heel Warmer (Chemical Heat Pack)

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    Other Clearances by Rapid Aid Corp.

    K Number Device Name
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