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

    SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE

    K Number: K003663 · Decision Jun 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    187
    Applicant Total
    35
    Review Days
    212

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    Basic Information

    Device Name
    SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE
    K Number
    K003663
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5160
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spacelabs Medical, Inc.
    Date Received
    November 28, 2000
    Decision Date
    June 28, 2001
    Product Code
    BSZ
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BSZ Gas-Machine, Anesthesia

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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
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