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

    STIMULUS/DISSECTION INSTRUMENTS

    K Number: K090838 · Decision Jul 20, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    96
    Applicant Total
    15
    Review Days
    115

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    Basic Information

    Device Name
    STIMULUS/DISSECTION INSTRUMENTS
    K Number
    K090838
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1820
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Axon Systems, Inc.
    Date Received
    March 27, 2009
    Decision Date
    July 20, 2009
    Product Code
    ETN
    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
    ETN Stimulator, Nerve

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    Other Clearances by Axon Systems, Inc.

    K Number Device Name
    K062996 DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES
    K062198 SUNSPOTS PRE-GELLED SURFACE ELECTRODES
    K061639 ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON
    K061113 ORTHOMON
    K050798 ECLIPSE NEUROLOGICAL WORKSTATION
    K050194 AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES
    K032741 EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION
    K022785 EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION
    K010697 UNIQUE AMBULATORY EEG
    K002316 PHOENIX DIGITAL EEG
    Search all 15 clearances from Axon Systems, Inc. →