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

    MODIFIED LASERFLO BLOOD PERFUSION MONITOR

    K Number: K864259 · Decision Feb 20, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    136
    Applicant Total
    4
    Review Days
    114

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    Basic Information

    Device Name
    MODIFIED LASERFLO BLOOD PERFUSION MONITOR
    K Number
    K864259
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Tsi, Inc.
    Date Received
    October 29, 1986
    Decision Date
    February 20, 1987
    Product Code
    DPW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DPW Flowmeter, Blood, Cardiovascular

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    Other Clearances by Tsi, Inc.

    K Number Device Name
    K896515 LASERFLO BLOOD PERFUSION MONITOR, MODEL BPM2
    K875179 MODIFIED LASERFLO BLOOD PERFUSION MONITOR, BPM403A
    K851057 LASERFLO BLOOD PERFUSION MONITOR 403