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

    A16 BLOOD FLOW MEASUREMENT SYSTEM

    K Number: K023707 · Decision Feb 12, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    52
    Applicant Total
    19
    Review Days
    100

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    Basic Information

    Device Name
    A16 BLOOD FLOW MEASUREMENT SYSTEM
    K Number
    K023707
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2780
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    D. E. Hokanson, Inc.
    Date Received
    November 4, 2002
    Decision Date
    February 12, 2003
    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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    Other Clearances by D. E. Hokanson, Inc.

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    K973426 ANS 2000 ECG MONITOR AND RESPIRATION PACER
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    K932852 NON INVASIVE VASCULAR PROGRAM
    K932812 EC 5R PLETHYSMOGRAPH
    K932851 DISPOSABLE PENILE BLOOD PRESSURE CUFFS
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