BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    X-RAY COLLIMATOR X-CJD

    K Number: K834606 · Decision Feb 21, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    55

    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
    X-RAY COLLIMATOR X-CJD
    K Number
    K834606
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.1840
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Knochen Dental Laboratory
    Date Received
    December 28, 1983
    Decision Date
    February 21, 1984
    Product Code
    EHB
    Advisory Committee
    Dental
    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
    EHB Collimator, X-Ray

    Similar 510(k) Clearances

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

    WINGMASTER

    FDA 510(k)
    FDA Class 1 ·Dental

    AUDIOPRAT ENDOSCOPE

    FDA 510(k)
    FDA Class 1 ·Dental

    X-RAY SHIELD

    FDA 510(k)
    FDA Class 1 ·Dental

    X-RAY COLLIMATOR

    FDA 510(k)
    FDA Class 1 ·Dental
    View all

    Other Clearances by Knochen Dental Laboratory

    K Number Device Name
    K834559 DELUXE WALL-MOUNTED CEPHALOMETER