BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    REMBRANDT SYSTEM

    K Number: K962865 · Decision Oct 25, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    15
    Applicant Total
    18
    Review Days
    94

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    Basic Information

    Device Name
    REMBRANDT SYSTEM
    K Number
    K962865
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2377
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    Airsep Corp.
    Date Received
    July 23, 1996
    Decision Date
    October 25, 1996
    Product Code
    FLS
    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
    FLS Monitor, Apnea, Facility Use

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