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

    FLOSCOPE MICRODOP

    K Number: K910441 · Decision Mar 21, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    47
    Applicant Total
    5
    Review Days
    49

    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
    FLOSCOPE MICRODOP
    K Number
    K910441
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Advance Medical Device, Inc.
    Date Received
    January 31, 1991
    Decision Date
    March 21, 1991
    Product Code
    DPT
    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
    DPT Probe, Blood-Flow, Extravascular

    Similar 510(k) Clearances

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

    Laser Speckle Imaging System (RFLSI CZW)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Deltex Medical KDP72 Doppler Probe

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIO-PROBE TRANSDUCER (ADULT)

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

    Other Clearances by Advance Medical Device, Inc.

    K Number Device Name
    K964697 AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION
    K943200 FLOSCOPE SUPER VASCULAR LAB
    K905157 FLOSCOPE VASCULAR LAB.
    K903744 PHYSICIAN'S CHOICE