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

    E-20 RAPID CUFF INFLATOR

    K Number: K905367 · Decision Mar 6, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    19
    Review Days
    99

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    E-20 RAPID CUFF INFLATOR
    K Number
    K905367
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    D. E. Hokanson, Inc.
    Date Received
    November 27, 1990
    Decision Date
    March 6, 1991
    Product Code
    DXN
    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
    DXN System, Measurement, Blood-Pressure, Non-Invasive

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DXN), ordered by most recent decision date.

    Wrist Blood Pressure Monitor (XW-05)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VicorderCS (VCS-SYS-1100)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Upper arm electronic blood pressure monitor (XB-01)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Blood Pressure Monitor (W06LT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by D. E. Hokanson, Inc.

    K Number Device Name
    K041689 POLYURETHANE BLOOD PRESSURE CUFFS
    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
    K901592 MODEL MD-5 DOPPLER
    Search all 19 clearances from D. E. Hokanson, Inc. →