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

    PULSE HEART RATE MONITOR

    K Number: K943243 · Decision Mar 10, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    2
    Review Days
    247

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    Basic Information

    Device Name
    PULSE HEART RATE MONITOR
    K Number
    K943243
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sensor Dynamics, Inc.
    Date Received
    July 6, 1994
    Decision Date
    March 10, 1995
    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 Sensor Dynamics, Inc.

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    K943242 PRO-SPORT HEART RATE MONITOR