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

    SPACELABS MEDICAL MULTIPARAMETER MODULE 91496

    K Number: K050175 · Decision Mar 4, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    35
    Review Days
    37

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    Basic Information

    Device Name
    SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
    K Number
    K050175
    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
    January 26, 2005
    Decision Date
    March 4, 2005
    Product Code
    DSI
    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
    DSI Detector And Alarm, Arrhythmia

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    Other Clearances by Spacelabs Medical, Inc.

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    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
    K062278 SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847
    K060900 SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842
    K053599 SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES
    Search all 35 clearances from Spacelabs Medical, Inc. →