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

    PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)

    K Number: K990960 · Decision Sep 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    16
    Applicant Total
    6
    Review Days
    185

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    Basic Information

    Device Name
    PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)
    K Number
    K990960
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2480
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Perimed, Inc.
    Date Received
    March 22, 1999
    Decision Date
    September 23, 1999
    Product Code
    LKD
    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
    LKD Monitor, Carbon-Dioxide, Cutaneous

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    Other Clearances by Perimed, Inc.

    K Number Device Name
    K974285 PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT
    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