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

    BIO-SENSOR 01 EKG ELECTRODE

    K Number: K911472 · Decision Oct 10, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    328
    Applicant Total
    1
    Review Days
    190

    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
    BIO-SENSOR 01 EKG ELECTRODE
    K Number
    K911472
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Bio-Sensor, Inc.
    Date Received
    April 3, 1991
    Decision Date
    October 10, 1991
    Product Code
    DRX
    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
    DRX Electrode, Electrocardiograph

    Similar 510(k) Clearances

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

    Physiotrace

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIOMODULE 3-M1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IP-SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X

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