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

    CARDIOBEEPER PROFILE MONITOR

    K Number: K844966 · Decision Feb 8, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    296
    Applicant Total
    10
    Review Days
    46

    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
    CARDIOBEEPER PROFILE MONITOR
    K Number
    K844966
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2920
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Survival Technology, Inc.
    Date Received
    December 24, 1984
    Decision Date
    February 8, 1985
    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 Survival Technology, Inc.

    K Number Device Name
    K925535 CARDIOBEEPER(R) CB-IIA
    K894799 CARDIOBEEPER MEMORY MONITOR CB 600 SERIES
    K890461 CARDIOBEEPER IV
    K883843 CARDIOBEEPER II
    K883614 CYTOGUARD(R)
    K880300 CARDIOBEEPER(R) III
    K822093 STAT-SCAN
    K813101 CARDIOBEEPER MEMORY MONITOR
    K772178 PACER MONITOR, PULSE WIDTH