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

    REVERSING CLICK GENERATOR RCG6

    K Number: K771188 · Decision Jul 14, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    29
    Review Days
    13

    Basic Information

    Device Name
    REVERSING CLICK GENERATOR RCG6
    K Number
    K771188
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1120
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    TECA, INC.
    Date Received
    July 1, 1977
    Decision Date
    July 14, 1977
    Product Code
    ETS
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ETS Generator, Electronic Noise (For Audiometric Testing)

    Similar 510(k) Clearances

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

    AUDITORY STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    AUDITORY LOCALIZER

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    OCTOTOXIC SCREENER

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    TINNITUS DEVICES

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by TECA, INC.

    K Number Device Name
    K962283 EEG ELECTRODES
    K903731 SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME
    K903004 EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH
    K896666 P460, DG32 ELECTROENCEPHALOGRAPH
    K894889 TECA NEUROMAPPER 386
    K894088 TECA NEUROMAPPER 1620, BRAIN MAPPER
    K890881 TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS
    K884870 TECA/MEDELEC 'CONCEPT' P420
    K880593 TECA/MEDELEC MISTRAL
    K872931 TECA/MEDELEC TTT THERMAL THRESHOLD TESTER
    Search all 29 clearances from TECA, INC. →