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

    MTI WOLFF SYSTEM

    K Number: K881353 · Decision Apr 6, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    80
    Applicant Total
    4
    Review Days
    7

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    Basic Information

    Device Name
    MTI WOLFF SYSTEM
    K Number
    K881353
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4635
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Health Systems Intl., Inc.
    Date Received
    March 30, 1988
    Decision Date
    April 6, 1988
    Product Code
    LEJ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LEJ Booth, Sun Tan

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    Other Clearances by Health Systems Intl., Inc.

    K Number Device Name
    K874232 MUSCLE STIM. DEVICES, BM 2000,4000,6000,8000
    K881492 MTI WOLFF SYSTEM, TANNING BED
    K862372 ULTRATAN TANNING SYSTEM