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

    THE MCP-70-SE SYSTEM

    K Number: K844180 · Decision Feb 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    5
    Review Days
    98

    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
    THE MCP-70-SE SYSTEM
    K Number
    K844180
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5900
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Ellis Pharmaceutical Consulting, Inc.
    Date Received
    October 26, 1984
    Decision Date
    February 1, 1985
    Product Code
    KQA
    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
    KQA Device, Beam Limiting, X-Ray, Therapeutic

    Similar 510(k) Clearances

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

    PAPILLION PROCTOSCOPE

    FDA 510(k)
    FDA Class 2 ·Radiology

    PHILIPS RT250 COLLIMATOR (PK8050)

    FDA 510(k)
    FDA Class 2 ·Radiology

    COLLIMATOR, BILATERIAL

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

    Other Clearances by Ellis Pharmaceutical Consulting, Inc.

    K Number Device Name
    K910936 EMPTY I.V. CONTAINER
    K884233 QUADROJECT(TM)
    K852235 STERETS INJECTION SWAB
    K832789 AFTER LOADING BUCHLER