BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4

    K Number: K910624 · Decision Jan 17, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    12
    Applicant Total
    6
    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
    CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4
    K Number
    K910624
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    882.1200
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Wr Medical Electronics Co.
    Date Received
    February 12, 1991
    Decision Date
    January 17, 1992
    Product Code
    LLN
    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
    LLN Device, Vibration Threshold Measurement

    Similar 510(k) Clearances

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

    PAIN VISION, MODEL PS-2100

    FDA 510(k)
    FDA Class 1 ·Neurology

    VPT METER

    FDA 510(k)
    FDA Class 1 ·Neurology

    GSA GENITO SENSORY ANALYZER

    FDA 510(k)
    FDA Class 1 ·Neurology

    MEDI-DX 7000

    FDA 510(k)
    FDA Class 1 ·Neurology

    AP-4000, AIR PULSE SENSORY STIMULATOR

    FDA 510(k)
    FDA Class 1 ·Neurology

    VSA 3000 VIBRATORYN SENSORY ANALYZER

    FDA 510(k)
    FDA Class 1 ·Neurology
    View all

    Other Clearances by Wr Medical Electronics Co.

    K Number Device Name
    K092809 HRV ACQUIRE
    K063560 HILGER DUAL-STIM NERVE STIMULATOR
    K000574 IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)
    K992874 Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM
    K895838 BRACKMANN EMG MONITORING SYSTEM