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

    EUB-40

    K Number: K844128 · Decision Feb 25, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    32
    Review Days
    125

    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
    EUB-40
    K Number
    K844128
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1540
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Hitachi Medical Corp. of America
    Date Received
    October 23, 1984
    Decision Date
    February 25, 1985
    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 Hitachi Medical Corp. of America

    K Number Device Name
    K994026 EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER
    K991535 CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
    K991318 CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
    K991129 HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL
    K981434 EUP-OL334 LAPARASCOPICPROBE
    K954220 EUB-8000
    K962308 EUB-905
    K954143 HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS
    K954129 SPECTRADIGITAL SERIES V250DSP
    K945400 HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100
    Search all 32 clearances from Hitachi Medical Corp. of America →