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

    MULTI DOPPLEX, MD-1

    K Number: K900882 · Decision Aug 22, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    23
    Review Days
    177

    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
    MULTI DOPPLEX, MD-1
    K Number
    K900882
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1540
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Huntleigh Technology, Inc.
    Date Received
    February 26, 1990
    Decision Date
    August 22, 1990
    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 Huntleigh Technology, Inc.

    K Number Device Name
    K992733 AKRON ATP9 TRACTION MACHINE
    K964699 RHEO DOPPLEX II (RD 2)
    K924516 OP3/VP4
    K910188 FLOWPLUS AC330 PUMP GARMENTS
    K900618 HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140
    K890012 HUNTLEIGH DYNAMIC FLOTATION SYSTEM
    K884451 DOPCORD PPG
    K881632 FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT
    K874688 FLOWTRON AC200/2
    K882644 HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5
    Search all 23 clearances from Huntleigh Technology, Inc. →