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

    PHYSIO-DYNE ECG/HR 3

    K Number: K854847 · Decision Jun 16, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    1
    Review Days
    194

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    Basic Information

    Device Name
    PHYSIO-DYNE ECG/HR 3
    K Number
    K854847
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Physio-Dyne Industrument Corp.
    Date Received
    December 4, 1985
    Decision Date
    June 16, 1986
    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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