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

    ECLIPSE NEUROLOGICAL WORKSTATION

    K Number: K050798 · Decision Aug 15, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    138
    Applicant Total
    15
    Review Days
    139

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    Basic Information

    Device Name
    ECLIPSE NEUROLOGICAL WORKSTATION
    K Number
    K050798
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1870
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Axon Systems, Inc.
    Date Received
    March 29, 2005
    Decision Date
    August 15, 2005
    Product Code
    GWF
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GWF Stimulator, Electrical, Evoked Response

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    Other Clearances by Axon Systems, Inc.

    K Number Device Name
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    K062198 SUNSPOTS PRE-GELLED SURFACE ELECTRODES
    K061639 ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON
    K061113 ORTHOMON
    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
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