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

    BP-8800 BLOOD PRESSURE MONITOR

    K Number: K890876 · Decision Jun 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    15
    Review Days
    121

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    Basic Information

    Device Name
    BP-8800 BLOOD PRESSURE MONITOR
    K Number
    K890876
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Colin Medical Instruments Corp.
    Date Received
    February 21, 1989
    Decision Date
    June 22, 1989
    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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