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

    OTOACOUSTIC EMISSIONS UNIT CELESTA 503

    K Number: K931325 · Decision Feb 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    234
    Applicant Total
    17
    Review Days
    339

    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
    OTOACOUSTIC EMISSIONS UNIT CELESTA 503
    K Number
    K931325
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1050
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Madsen Electronics (Canada) , Ltd.
    Date Received
    March 16, 1993
    Decision Date
    February 18, 1994
    Product Code
    EWO
    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
    EWO Audiometer

    Similar 510(k) Clearances

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

    OtoNova/OtoNova Pro

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

    Otoport Pro

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

    hearOAE

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

    Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE

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

    Lyra

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

    GSI Corti

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

    Other Clearances by Madsen Electronics (Canada) , Ltd.

    K Number Device Name
    K942749 HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT
    K931324 ORBITER 922 CLINICAL AUDIOMETER
    K910247 ZODIAC 901 MIDDLE-EAR ANALYZER
    K884372 MADSEN IGO1500 INSERTION GAIN OPTIMIZER
    K884371 MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM
    K883478 DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602
    K874354 AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020
    K870229 HEARING AID TEST SYSTEM MODEL HAT 1000
    K861905 PLOTTER MODEL (MP100)
    K854533 SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2
    Search all 17 clearances from Madsen Electronics (Canada) , Ltd. →