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

    COLLIMATOR, MODEL M-38

    K Number: K062788 · Decision Dec 28, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    101

    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
    COLLIMATOR, MODEL M-38
    K Number
    K062788
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1610
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Umi International
    Date Received
    September 18, 2006
    Decision Date
    December 28, 2006
    Product Code
    KPW
    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
    KPW Device, Beam Limiting, X-Ray, Diagnostic

    Similar 510(k) Clearances

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

    LUMOS, MODEL R 72B

    FDA 510(k)
    FDA Class 2 ·Radiology

    R 72

    FDA 510(k)
    FDA Class 2 ·Radiology

    BLA-800A

    FDA 510(k)
    FDA Class 2 ·Radiology

    R 302

    FDA 510(k)
    FDA Class 2 ·Radiology

    P2020-8-0 BEAM-LIMITING DEVICE

    FDA 510(k)
    FDA Class 2 ·Radiology

    DENSICOMP 250

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