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

    TRACER

    K Number: K982617 · Decision Apr 9, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    59
    Applicant Total
    1
    Review Days
    256

    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
    TRACER
    K Number
    K982617
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Heartland Medical Systems, Inc.
    Date Received
    July 27, 1998
    Decision Date
    April 9, 1999
    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