BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Infant Heel WarmerTM; Heel Snuggler®

    K Number: K221154 · Decision Oct 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    10
    Applicant Total
    8
    Review Days
    169

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    Basic Information

    Device Name
    Infant Heel WarmerTM; Heel Snuggler®
    K Number
    K221154
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5710
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    International Biomedical
    Date Received
    April 21, 2022
    Decision Date
    October 7, 2022
    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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