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

    SPACELABS MODEL 90419 PULSE OXIMETER MODULE

    K Number: K864279 · Decision Mar 11, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    46
    Review Days
    132

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    Basic Information

    Device Name
    SPACELABS MODEL 90419 PULSE OXIMETER MODULE
    K Number
    K864279
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Spacelabs, Inc.
    Date Received
    October 30, 1986
    Decision Date
    March 11, 1987
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    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
    DQA Oximeter

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    Other Clearances by Spacelabs, Inc.

    K Number Device Name
    K954962 SPACELABS MEDICAL MULTIGAS ANALYZER
    K951605 SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM
    K950779 HEART RATE VARIABILITY SOFTWARE OPTION
    K941165 COMET CAPNOGRAPH MODULE
    K923788 SPACE LABS MODEL 90560
    K912742 ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE
    K913038 SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION
    K905065 DEFIBRILLATOR LEAD ADAPTER
    K910029 PATIENT CARE MANAGEMENT SYSTEM MODIFICATION
    K896903 FIRST MEDIC MODEL 510
    Search all 46 clearances from Spacelabs, Inc. →