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

    PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT

    K Number: K974285 · Decision May 28, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    136
    Applicant Total
    6
    Review Days
    195

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    Basic Information

    Device Name
    PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT
    K Number
    K974285
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Perimed, Inc.
    Date Received
    November 14, 1997
    Decision Date
    May 28, 1998
    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 Perimed, Inc.

    K Number Device Name
    K990960 PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)
    K935495 PF404/409/410/411/416/418 W/PF319:0/319:1/319:2
    K932068 PERITEMP PF 4005 HEATER
    K922368 PERIFLUX PF4001 LASER DOPPLER FLOWMETER
    K890828 PERIFLUX PF3