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

    EAGLE 3000/3100 PATIENT MONITOR

    K Number: K960272 · Decision Oct 2, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    13
    Applicant Total
    82
    Review Days
    258

    Basic Information

    Device Name
    EAGLE 3000/3100 PATIENT MONITOR
    K Number
    K960272
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MARQUETTE ELECTRONICS, INC.
    Date Received
    January 18, 1996
    Decision Date
    October 2, 1996
    Product Code
    MLD
    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
    MLD Monitor, St Segment With Alarm

    Similar 510(k) Clearances

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

    VITAL SIGNS MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES

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

    Other Clearances by MARQUETTE ELECTRONICS, INC.

    K Number Device Name
    K971868 IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM
    K971683 WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET
    K972199 SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS
    K962547 CARDIOSERV P
    K963120 RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM
    K962827 ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)
    K964750 EAGLE 4000 PATIENT MONITOR
    K962551 CARDIOSERV S
    K960418 EAGLE PATIENT MONITOR
    K961139 EAGLE PATIENT MONITOR MODEL 3000/3100
    Search all 82 clearances from MARQUETTE ELECTRONICS, INC. →