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

    PULSE CUFF RECORDER MODEL PCR100

    K Number: K863702 · Decision Jun 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    52
    Applicant Total
    19
    Review Days
    262

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    Basic Information

    Device Name
    PULSE CUFF RECORDER MODEL PCR100
    K Number
    K863702
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2780
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Imex Medical Systems, Inc.
    Date Received
    September 23, 1986
    Decision Date
    June 12, 1987
    Product Code
    JOM
    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
    JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

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