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

    MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)

    K Number: K110410 · Decision Aug 4, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    31
    Applicant Total
    9
    Review Days
    171

    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
    MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)
    K Number
    K110410
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1310
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nihon Kohden Corp.
    Date Received
    February 14, 2011
    Decision Date
    August 4, 2011
    Product Code
    GYC
    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
    GYC Electrode, Cortical

    Similar 510(k) Clearances

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

    Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Layer 7-T

    FDA 510(k)
    FDA Class 2 ·Neurology

    WISE Cortical Strip (WCS)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid

    FDA 510(k)
    FDA Class 2 ·Neurology

    Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Nihon Kohden Corp.

    K Number Device Name
    K130238 NIHON KOHDEN AE-918P NEURO UNIT
    K122214 TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)
    K120888 PSG-1100 SLEEP DIAGNOSTIC SYSTEM
    K120397 MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM
    K110594 GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS
    K110376 PE-210AK SWITCH BOX
    K102106 NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION
    K102376 NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201