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

    LIFESCOPE 6 OEC-6201

    K Number: K841500 · Decision Aug 28, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    166
    Review Days
    140

    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
    LIFESCOPE 6 OEC-6201
    K Number
    K841500
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Nihon Kohden America, Inc.
    Date Received
    April 10, 1984
    Decision Date
    August 28, 1984
    Product Code
    DSI
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DSI Detector And Alarm, Arrhythmia

    Similar 510(k) Clearances

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

    BodyGuardian Remote Monitoring System (BGRMS v3.0)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Zio AT® device (A100A1001)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SmartCardia 7L Platform

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Unified Arrhythmia Diagnostic System PocketECG IV

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

    Other Clearances by Nihon Kohden America, Inc.

    K Number Device Name
    K113117 NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX
    K120485 NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P
    K092573 NIHON KOHDEN QP-160AK EEG TREND PROGRAM
    K083456 NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P
    K083271 BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY
    K082785 NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES
    K071969 SEN-4100 ELECTRIC STIMULATOR
    K080546 NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A
    K073550 PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION
    K080342 NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES
    Search all 166 clearances from Nihon Kohden America, Inc. →