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

    DTL ELECTRODE

    K Number: K844409 · Decision Feb 14, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    92

    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
    DTL ELECTRODE
    K Number
    K844409
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1220
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Sauquoit Industries, Inc.
    Date Received
    November 14, 1984
    Decision Date
    February 14, 1985
    Product Code
    HLZ
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HLZ Electrode, Corneal

    Similar 510(k) Clearances

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

    RM Electrode (RMH 25-01)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    RM Electrode (RMH 23-01)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TOMEY DTL ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SOPHER AND BIERER OVUM FORCEPS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    GOLDLENS(TM)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ERG-JET ELECTRODE

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