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

    Prestige Ameritech Pediatric/Child’s Face mask

    K Number: K160100 · Decision Oct 7, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    8
    Applicant Total
    5
    Review Days
    262

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    Basic Information

    Device Name
    Prestige Ameritech Pediatric/Child’s Face mask
    K Number
    K160100
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prestige Ameritech
    Date Received
    January 19, 2016
    Decision Date
    October 7, 2016
    Product Code
    OXZ
    Advisory Committee
    General, Plastic Surgery
    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
    OXZ Pediatric/Child Facemask

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    Other Clearances by Prestige Ameritech

    K Number Device Name
    K231741 ProGear® Surgical Mask with Oxafence®, Model AV82030
    K171162 Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield
    K102092 PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES
    K061716 PRESTIGE AMERITECH FACE MASK