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

    KENZ-ECG 102

    K Number: K863965 · Decision Dec 22, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    77
    Applicant Total
    6
    Review Days
    73

    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
    KENZ-ECG 102
    K Number
    K863965
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Compumed, Inc.
    Date Received
    October 10, 1986
    Decision Date
    December 22, 1986
    Product Code
    DXK
    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
    DXK Echocardiograph

    Similar 510(k) Clearances

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

    Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IN-VISION IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    9750 ATHENA ETHERNET OPTION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCESSORY TO GENESIS III (GCFM)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600

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

    Other Clearances by Compumed, Inc.

    K Number Device Name
    K984285 OSTEOGRAM BONE DENSITOMETER
    K955708 COMPUMED DICON CLIENT
    K854626 COMPUMED PULMONARY FUNCTION ANALYZER MODEL 307B
    K802272 COMPUTER ECG TERMINAL
    K771648 COMPUTER ECG TERMINAL