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

    DMS 300-2W HOLTER ECG RECORDER

    K Number: K133014 · Decision May 19, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    59
    Applicant Total
    5
    Review Days
    236

    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
    DMS 300-2W HOLTER ECG RECORDER
    K Number
    K133014
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diagnostic Monitoring Software
    Date Received
    September 25, 2013
    Decision Date
    May 19, 2014
    Product Code
    MWJ
    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
    MWJ Electrocardiograph, Ambulatory (Without Analysis)

    Similar 510(k) Clearances

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

    ZywieZ3 Sensor & Adhesive

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HeartBeam AIMIGo(TM) System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ASSURE Wearable ECG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Eclipse MINI Model 98900

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Biotres

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Q Patch

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

    Other Clearances by Diagnostic Monitoring Software

    K Number Device Name
    K062959 DMS 300-2, 300-3 AND 300-4
    K062088 PREMIER 11 HOLTER
    K062007 DMS 300-7
    K911615 HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300