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

    DermaTherapy Bed Linens

    K Number: K152884 · Decision Jun 20, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    210
    Same Product Code
    13
    Applicant Total
    2
    Review Days
    264

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    Basic Information

    Device Name
    DermaTherapy Bed Linens
    K Number
    K152884
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6190
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Precision Fabrics Group, Inc.
    Date Received
    September 30, 2015
    Decision Date
    June 20, 2016
    Product Code
    FMW
    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
    FMW Cover, Mattress (Medical Purposes)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FMW), ordered by most recent decision date.

    DERMATHERAPY, MODEL 22216

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    EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM

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    INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW

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    CORE PREVENT MATTRESS MODIFICATION

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    REUSABLE INCONTIENT UNDERPAD

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    Other Clearances by Precision Fabrics Group, Inc.

    K Number Device Name
    K061242 DERMATHERAPY, MODEL 22216