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

    SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847

    K Number: K062278 · Decision Sep 19, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    116
    Applicant Total
    35
    Review Days
    43

    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
    SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847
    K Number
    K062278
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spacelabs Medical, Inc.
    Date Received
    August 7, 2006
    Decision Date
    September 19, 2006
    Product Code
    MSX
    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
    MSX System, Network And Communication, Physiological Monitors

    Similar 510(k) Clearances

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

    IntelliVue Measurement Rack 6000 (867317)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TigerConnect Alarm Management

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BeneVision Central Monitoring System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Central Station

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANNE View, Central Hub

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Hinscope

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

    Other Clearances by Spacelabs Medical, Inc.

    K Number Device Name
    K120616 SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390
    K112962 SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)
    K102422 SPACELABS MEDICAL PATIENT MONITORS
    K093501 ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION
    K082045 MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
    K063490 SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810
    K062095 MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
    K060900 SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842
    K053599 SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES
    K050605 SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
    Search all 35 clearances from Spacelabs Medical, Inc. →