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

    LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433

    K Number: K951832 · Decision Mar 21, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    47
    Applicant Total
    6
    Review Days
    336

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    Basic Information

    Device Name
    LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433
    K Number
    K951832
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vasamedics, LLC
    Date Received
    April 20, 1995
    Decision Date
    March 21, 1996
    Product Code
    DPT
    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
    DPT Probe, Blood-Flow, Extravascular

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    Other Clearances by Vasamedics, LLC

    K Number Device Name
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    K961368 TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT
    K951486 MODEL PV2000 VASCULAR MICROLABORATORY
    K912446 MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2
    K911763 LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2)