Erg-Jet Electrode
FDA 510(k) K813399 · Nicolet Biomedical Instruments
510(k) numberK813399
Submission
- Device name
- Erg-Jet Electrode
- Applicant
- Nicolet Biomedical Instruments
Mchenry, IL, US - Received
- December 4, 1981
- Decision date
- January 22, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HLZ – Electrode, Corneal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1220
- Specialty
- Ophthalmic
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|---|---|---|---|
| K253586 | RM Electrode (RMH 25-01)HLZ · Traditional | Retmap, Inc. | 04/01/2026SE |
| K232273 | RM Electrode (RMH 23-01)HLZ · Traditional | Retmap, Inc. | 12/07/2023SE |
| K961805 | Tomey DTL ElectrodeHLZ · Traditional | Tomey Corporation USA | 05/09/1997SE |
| K926540 | Sopher and Bierer Ovum ForcepsHLZ · Traditional | Thomasville Medical Assoc. | 02/25/1994SE |
| K913239 | Goldlens(Tm)HLZ · Traditional | Doran Instruments, Inc. | 01/31/1992SE |
| K844409 | DTL ElectrodeHLZ · Traditional | Sauquoit Industries, Inc. | 02/14/1985SE |
| K830557 | Erg-Jet ElectrodeHLZ · Traditional | Universo S.A. | 03/31/1983SE |
| K820254 | Gold Foil Erg ElectrodesHLZ · Traditional | Cadwell Laboratories, Inc. | 04/09/1982SE |
| K781476 | Mular Gold Leaf Electrode Model 7501HLZ · Traditional | Life-Tech Instruments, Inc. | 11/15/1978SE |
| K760199 | ElectroretinographHLZ · Traditional | Lkc Technologies, Inc. | 08/04/1976SE |
More from Lkc Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880573 | Modified Nicolet Viking SystemIKN · Traditional | 03/22/1988SE |
| K873736 | Nicolet Digital Two Piece Hearing AidESD · Traditional | 12/08/1987SE |
| K873964 | Nicolet Disposable Prass ProbeETN · Traditional | 11/20/1987SE |
| K873535 | Nicolet Expert Sleep/Wake Analysis SystemGWQ · Traditional | 10/26/1987SE |
| K871678 | Nicolet Amp 6R11 SystemGWL · Traditional | 07/16/1987SE |
| K862592 | Phoenix System Seven.EWO · Traditional | 09/16/1986SE |
| K851190 | Nystagmograph Eog/Eng AnalysesGWN · Traditional | 11/27/1985SE |
| K850259 | Electroencephalograph EEGGWQ · Traditional | 04/11/1985SE |
| K850108 | Emg Surface, Digital Ring, Bar, Grounding, EEGGXY · Traditional | 04/11/1985SE |
| K850107 | Concentric Needle Electrodes-Various Sizes W/ConneGXZ · Traditional | 04/11/1985SE |
Questions and answers
When was Erg-Jet Electrode cleared by the FDA?
Erg-Jet Electrode (K813399) received a 510(k) decision of Substantially Equivalent on January 22, 1982, 49 days after the submission was received.
What is the product code of K813399?
The FDA product code is HLZ – Electrode, Corneal, a Class II (moderate risk) device regulated under 21 CFR 886.1220.