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

    SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES

    K Number: K073249 · Decision Jul 25, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    5
    Review Days
    249

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    Basic Information

    Device Name
    SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES
    K Number
    K073249
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Solaris Medical Technology, Inc.
    Date Received
    November 19, 2007
    Decision Date
    July 25, 2008
    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 Solaris Medical Technology, Inc.

    K Number Device Name
    K100077 NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103
    K101972 SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS
    K092950 SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES
    K061931 SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101