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

    MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)

    K Number: K863353 · Decision Nov 3, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    69
    Applicant Total
    16
    Review Days
    66

    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
    MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)
    K Number
    K863353
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1090
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Grason-Stadler, Inc.
    Date Received
    August 29, 1986
    Decision Date
    November 3, 1986
    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 Grason-Stadler, Inc.

    K Number Device Name
    K180287 GSI Corti
    K172403 GSI Novus
    K000097 GSI 2000 MIDDLE EAR ANALYZER
    K974237 GSI 70 AUDIOPATH SCREENER
    K970324 GSI SA60 DPOAE SYSTEM
    K953684 GSI 61 CLINICAL AUDIOMETER
    K951759 GSI 65 COMPUTERIZED AUDIOMETER
    K902540 GSI 17 SCREENING AUDIOMETER
    K890124 ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER
    K870030 THE SCREENER GSI 55 ABR SCREENER
    Search all 16 clearances from Grason-Stadler, Inc. →