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

    WISCONSIN HEART RATE MONITOR

    K Number: K802182 · Decision Oct 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    6
    Review Days
    52

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    Basic Information

    Device Name
    WISCONSIN HEART RATE MONITOR
    K Number
    K802182
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Lunar Radiation Corp.
    Date Received
    September 9, 1980
    Decision Date
    October 31, 1980
    Product Code
    DRT
    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
    DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

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    Other Clearances by Lunar Radiation Corp.

    K Number Device Name
    K873296 DPX BONE DENSITOMETER
    K810140 DUAL-PHOTON TOTAL BODY BONE MINERAL ANA
    K810159 BONE MINERAL ANALYZER CONTROLLER
    K802181 WISCONSIN BONE MINERAL ANALYZER
    K802180 WISCONSIN DUAL-PHOTON BONE ANALYZER