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

    MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220

    K Number: K082045 · Decision Aug 1, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    35
    Review Days
    14

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    Basic Information

    Device Name
    MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
    K Number
    K082045
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spacelabs Medical, Inc.
    Date Received
    July 18, 2008
    Decision Date
    August 1, 2008
    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 Spacelabs Medical, Inc.

    K Number Device Name
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    K063490 SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810
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    K060900 SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842
    K053599 SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES
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