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

    DOPPLER GUIDED PROCTOSCOPE, MODEL 500H

    K Number: K052067 · Decision Aug 29, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    8
    Review Days
    28

    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
    DOPPLER GUIDED PROCTOSCOPE, MODEL 500H
    K Number
    K052067
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1540
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Multigon Industries, Inc.
    Date Received
    August 1, 2005
    Decision Date
    August 29, 2005
    Product Code
    JAF
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JAF Monitor, Ultrasonic, Nonfetal

    Similar 510(k) Clearances

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

    Laminar P1 (LDH-HW-001)

    FDA 510(k)
    FDA Class 2 ·Radiology

    THD REVOLUTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    SIMPLEABI

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIFEDOP MODEL 300ABI

    FDA 510(k)
    FDA Class 2 ·Radiology

    THD SLIDE ONE

    FDA 510(k)
    FDA Class 2 ·Radiology

    THD SLIDE

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

    Other Clearances by Multigon Industries, Inc.

    K Number Device Name
    K051739 POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPLER ULTRAOUND PROBE, MODEL 2MPB.
    K912044 MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR
    K881263 MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER
    K882755 MODEL 500V VASCULAR SPECTRUM ANALYZER
    K863589 MODEL 600 VASCULAR DUPLEX IMAGER
    K860435 MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER
    K852680 TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG