BEUDAMED
    Product Code: GXW FDA class 2 21 CFR 882.1240

    Echoencephalograph

    Neurology

    The Echoencephalograph is a neurological diagnostic device that uses ultrasound to examine intracranial structures, historically used to detect midline shifts caused by brain tumors, hemorrhage, or other mass lesions. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is GXW under regulation 21 CFR 882.1240 in the Neurology specialty. It is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    7
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    6
    Years Active
    15

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    Basic Information

    Product Code
    GXW
    Device Class
    FDA class 2
    Regulation Number
    882.1240
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 7 510(k) clearances via K numbers.

    K Number Device Name
    K921863 SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS
    K903085 SMS-712NA
    K853432 5.0 IOP & 7.5 IOP PROBES
    K833522 NEURO SECTOR FIXATION DEVICE
    K821736 ECHO-PULSE KM555
    K770788 ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000
    K770575 ECHOENCEPHALOGRAPH, DIGITAL, 1000