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

    PACEMAKER SYS. ANALYZER 378

    K Number: K832959 · Decision Nov 14, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    63
    Review Days
    76

    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
    PACEMAKER SYS. ANALYZER 378
    K Number
    K832959
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3640
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Siemens Elema AB
    Date Received
    August 30, 1983
    Decision Date
    November 14, 1983
    Product Code
    KRE
    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
    KRE Analyzer, Pacemaker Generator Function, Indirect

    Similar 510(k) Clearances

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

    PACEART OPTIMA SYSTEM SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CYGNUS 12 LEAD ECG MODULE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EKG SPEAKS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HPM 40 HEART PACEMAKER MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PACEART CPTS-86/12

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PACEVIEW

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

    Other Clearances by Siemens Elema AB

    K Number Device Name
    K023354 COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E
    K010923 KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E
    K010925 SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
    K002137 CATHCOR DESKTOP
    K001315 MODIFICATION TO KION ANESTHESIA SYSTEM
    K970839 SERVO VENTILATOR 300A
    K960010 SERVO VENTILATOR 300 COMPUTER INTERFACE
    K960168 SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990
    K872278 SIEMENS O2-AIR MIXER 965
    K871354 SERVO VENTILATOR 900 C/D
    Search all 63 clearances from Siemens Elema AB →