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

    AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B

    K Number: K854043 · Decision Dec 31, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    69
    Applicant Total
    13
    Review Days
    90

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B
    K Number
    K854043
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1090
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Teledyne Avionics Div. of Teledyne
    Date Received
    October 2, 1985
    Decision Date
    December 31, 1985
    Product Code
    ETY
    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
    ETY Tester, Auditory Impedance

    Similar 510(k) Clearances

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

    Hearing Healthcare Pro

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

    Hearing Healthcare Pro

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

    touchTymp

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

    Madsen Zodiac

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

    AT235

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

    GSI TympStar Pro Middle Ear Analyzer

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

    Other Clearances by Teledyne Avionics Div. of Teledyne

    K Number Device Name
    K860262 TA-6C - PART NUMBER SLZ 7520
    K860522 SPIROMETER, MODEL TS-1000, PART NO. SLZ7504
    K855068 SPIROMETER, MODEL TS-500 PART #SLZ7534
    K855070 SPIROMETER MODEL TS-200 SLZ 7541
    K855069 SPIROMETER TS-400 SLZ 7547
    K851015 TA-20 AUTOMATIC INDUSTIRAL AUDIOMETER
    K850461 AUTOMATIC IMPEDANCE METER TA-7A
    K844069 TA-201 CLINICAL AUDIOMETER
    K811509 AUTO-TYMPANIGRAPH (TA-5A)
    K801325 CLINICAL AUDIOMETER MODEL TA-200
    Search all 13 clearances from Teledyne Avionics Div. of Teledyne →