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

    ERG-JET ELECTRODE

    K Number: K813399 · Decision Jan 22, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    10
    Applicant Total
    26
    Review Days
    49

    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
    ERG-JET ELECTRODE
    K Number
    K813399
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1220
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Nicolet Biomedical Instruments
    Date Received
    December 4, 1981
    Decision Date
    January 22, 1982
    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

    DTL ELECTRODE

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

    Other Clearances by Nicolet Biomedical Instruments

    K Number Device Name
    K880573 MODIFIED NICOLET VIKING SYSTEM
    K873736 NICOLET DIGITAL TWO PIECE HEARING AID
    K873964 NICOLET DISPOSABLE PRASS PROBE
    K873535 NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM
    K871678 NICOLET AMP 6R11 SYSTEM
    K862592 PHOENIX SYSTEM SEVEN.
    K851190 NYSTAGMOGRAPH EOG/ENG ANALYSES
    K850108 EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG
    K850107 CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE
    K850259 ELECTROENCEPHALOGRAPH EEG
    Search all 26 clearances from Nicolet Biomedical Instruments →