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

    TETRA NATAL-MAT WATER FLOTATION MAT.

    K Number: K802833 · Decision Dec 10, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    154
    Registration Numbers
    154
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    28

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    Basic Information

    Device Name
    TETRA NATAL-MAT WATER FLOTATION MAT.
    K Number
    K802833
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5150
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Tetra Group U.S.A., Inc.
    Date Received
    November 12, 1980
    Decision Date
    December 10, 1980
    Product Code
    IKY
    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
    IKY Mattress, Flotation Therapy, Non-Powered

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