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

    PHILIPS BV 300 SERIES

    K Number: K953910 · Decision Oct 18, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    81
    Applicant Total
    71
    Review Days
    58

    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
    PHILIPS BV 300 SERIES
    K Number
    K953910
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems North America, Inc.
    Date Received
    August 21, 1995
    Decision Date
    October 18, 1995
    Product Code
    OXO
    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
    OXO Image-Intensified Fluoroscopic X-Ray System, Mobile

    Similar 510(k) Clearances

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

    Digital C-ARM with 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    Orthoscan TAU MVP Mini C-Arm System

    FDA 510(k)
    FDA Class 2 ·Radiology

    OEC One CFD

    FDA 510(k)
    FDA Class 2 ·Radiology

    Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Orthoscan TAU Mini C-Arm

    FDA 510(k)
    FDA Class 2 ·Radiology

    Orthoscan VERSA Mini C-Arm

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

    Other Clearances by Philips Medical Systems North America, Inc.

    K Number Device Name
    K102005 ALLURA XPER OR TABLE SERIES
    K062233 HEARTSTART MRX MONITOR/DEFIBRILLATOR
    K062283 THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS
    K061052 THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90
    K050151 MULTIDIAGNOST ELEVA
    K042867 PHILIPS ORTHOPAEDIC APPLICATIONS
    K041602 PANORAMA 1.0T
    K033737 ALLURA XPER FD20
    K031333 PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2
    K013894 TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T
    Search all 71 clearances from Philips Medical Systems North America, Inc. →