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

    OXISCAN II DATA MANAGEMENT SYSTEM

    K Number: K080348 · Decision Oct 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    18
    Review Days
    241

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    Basic Information

    Device Name
    OXISCAN II DATA MANAGEMENT SYSTEM
    K Number
    K080348
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Airsep Corp.
    Date Received
    February 11, 2008
    Decision Date
    October 9, 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 Airsep Corp.

    K Number Device Name
    K101154 CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L
    K020324 LIFESTYLE OXYGEN CONCENTRATOR
    K012037 HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009
    K000963 DA VINCHI EEG AND EMG/EP SYSTEMS
    K001579 IMPULSE SELECT
    K001467 DA VINCHI EMG/EP ISA1004EP
    K001013 MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
    K992283 ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
    K983002 MYSTIQUE ULTRASONIC NEBULIZER
    K960309 AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)
    Search all 18 clearances from Airsep Corp. →