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

    SUPERLITE PENLIGHT

    K Number: K861028 · Decision Apr 4, 1986
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    3
    Review Days
    17

    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
    SUPERLITE PENLIGHT
    K Number
    K861028
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Applicant
    Keta Corp.
    Date Received
    March 18, 1986
    Decision Date
    April 4, 1986
    Advisory Committee
    Unknown
    Review Advisory Committee
    OP
    Third Party
    N

    Other Clearances by Keta Corp.

    K Number Device Name
    K861027 KETA HAND-HELD TONOMETER
    K844570 QUANTUM 412