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

    POLYURETHANE BLOOD PRESSURE CUFFS

    K Number: K041689 · Decision Aug 6, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    19
    Review Days
    45

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    Basic Information

    Device Name
    POLYURETHANE BLOOD PRESSURE CUFFS
    K Number
    K041689
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    D. E. Hokanson, Inc.
    Date Received
    June 22, 2004
    Decision Date
    August 6, 2004
    Product Code
    DXQ
    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
    DXQ Blood Pressure Cuff

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    Other Clearances by D. E. Hokanson, Inc.

    K Number Device Name
    K033156 OB1 OBSTETRICAL DOPPLER
    K023707 A16 BLOOD FLOW MEASUREMENT SYSTEM
    K982707 EC6 PLETHYSMOGRAPH
    K973426 ANS 2000 ECG MONITOR AND RESPIRATION PACER
    K970570 NIVP3 (WINDOWS VERSION OF NIVP
    K932852 NON INVASIVE VASCULAR PROGRAM
    K932812 EC 5R PLETHYSMOGRAPH
    K932851 DISPOSABLE PENILE BLOOD PRESSURE CUFFS
    K905367 E-20 RAPID CUFF INFLATOR
    K901592 MODEL MD-5 DOPPLER
    Search all 19 clearances from D. E. Hokanson, Inc. →