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

    SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES

    K Number: K920445 · Decision Mar 2, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    15
    Review Days
    392

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    Basic Information

    Device Name
    SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES
    K Number
    K920445
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Medical Electronics
    Date Received
    February 4, 1992
    Decision Date
    March 2, 1993
    Product Code
    MHX
    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
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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    Other Clearances by Siemens Medical Electronics

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    K912070 SIEMENS RADIOTOM 904 & 904E ELECTROSURGERY UNIT
    K913489 SIEMENS MICRO2 PULSE OXIMETER
    K905775 SIEMENS ETCO2 CARTRIDGE
    K900319 SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM
    K901771 SIEMENS SIRECUST 732, PATIENT MONITOR
    K894460 SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIA
    K891481 SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE
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