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

    KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II

    K Number: K983626 · Decision Feb 5, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    296
    Applicant Total
    16
    Review Days
    113

    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
    KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II
    K Number
    K983626
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.2920
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alaris Medical Systems, Inc.
    Date Received
    October 15, 1998
    Decision Date
    February 5, 1999
    Product Code
    DXH
    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
    DXH Transmitters And Receivers, Electrocardiograph, Telephone

    Similar 510(k) Clearances

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

    PreemptiveAI Clinical SDK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HeartBeam AIMIGo with 12-L ECG Synthesis Software System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEMO Patch M (MPT-E08R-UNC01)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Hexoskin Medical System (7100-00016)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VitalSigns 1-Lead Holter (VSH101)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QT ECG (QTERD100)

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

    Other Clearances by Alaris Medical Systems, Inc.

    K Number Device Name
    K043299 MEDLEY PCA MODULE, MODEL 8120
    K041241 MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600
    K031741 MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300
    K032233 MEDLEY PCA MODULE, MODEL 8120
    K032147 SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES
    K030459 MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS)
    K023264 MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110
    K022677 MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE
    K022209 ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS
    K013087 SINGLE DOSE DISPENSING PIN, MODEL 2201
    Search all 16 clearances from Alaris Medical Systems, Inc. →