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

    SUN TANNING BED MODEL EC-3RF

    K Number: K853692 · Decision Oct 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    9
    Review Days
    27

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    Basic Information

    Device Name
    SUN TANNING BED MODEL EC-3RF
    K Number
    K853692
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Mottek Intl. Corp.
    Date Received
    September 4, 1985
    Decision Date
    October 1, 1985
    Product Code
    FTC
    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
    FTC Light, Ultraviolet, Dermatological

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    Other Clearances by Mottek Intl. Corp.

    K Number Device Name
    K860198 MODEL 7500/000 KETTLER HOLIDAY SOLAR SUN TANNING
    K855162 ULTRAVIOLET SUN TANNING UNIT KETTLER HOLIDAY SOLAR
    K854932 ECUMOL ULTRAVIOLET FACE TANNING UNITS
    K853177 ECUMOL ULTRAVIOLET SUNTANNNING BEDS
    K852243 KETTLER ULTRAVIOLET SUNTANNING BENCHES & LIFTS
    K852053 ORIGINAL ULTRAVIOLET SUNTANNING LAMP
    K843814 EMUMOL ULTRAVIOLET SUNTANNING LAMP
    K802134 JK INT'L, INC. SOLTRON UVA TANNING BED