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

    FIRST TOUCH/VILEDON NON-WOVEN FILTER

    K Number: K915752 · Decision Sep 17, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    81
    Applicant Total
    2
    Review Days
    269

    Basic Information

    Device Name
    FIRST TOUCH/VILEDON NON-WOVEN FILTER
    K Number
    K915752
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5400
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    FIRST TOUCH DISPOSABLES, INC.
    Date Received
    December 23, 1991
    Decision Date
    September 17, 1992
    Product Code
    FMZ
    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
    FMZ Incubator, Neonatal

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    Other Clearances by FIRST TOUCH DISPOSABLES, INC.

    K Number Device Name
    K950422 FIRST TOUCH DISPOSABLES TEMPERATURE PROBES