BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Otowave 202 Portable Tympanometer

    K Number: K150163 · Decision Apr 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    3
    Review Days
    87

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    Basic Information

    Device Name
    Otowave 202 Portable Tympanometer
    K Number
    K150163
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1090
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Amplivox, Ltd.
    Date Received
    January 26, 2015
    Decision Date
    April 23, 2015
    Product Code
    NAS
    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
    NAS Tympanometer

    Similar 510(k) Clearances

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

    Otowave 302 Portable Tympanometer

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

    Other Clearances by Amplivox, Ltd.

    K Number Device Name
    K171265 Otowave 302 Portable Tympanometer
    K081841 AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER