Erg-Jet Electrode
FDA 510(k) K830557 · Universo S.A.
510(k) numberK830557
Submission
- Device name
- Erg-Jet Electrode
- Applicant
- Universo S.A.
Walker, MI, US - Received
- February 23, 1983
- Decision date
- March 31, 1983
- 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
Other 510(k)s with product code HLZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K820254 | Gold Foil Erg ElectrodesHLZ · Traditional | Cadwell Laboratories, Inc. | 04/09/1982SE |
| K813399 | Erg-Jet ElectrodeHLZ · Traditional | Nicolet Biomedical Instruments | 01/22/1982SE |
| K781476 | Mular Gold Leaf Electrode Model 7501HLZ · Traditional | Life-Tech Instruments, Inc. | 11/15/1978SE |
| K760199 | ElectroretinographHLZ · Traditional | Lkc Technologies, Inc. | 08/04/1976SE |
Questions and answers
When was Erg-Jet Electrode cleared by the FDA?
Erg-Jet Electrode (K830557) received a 510(k) decision of Substantially Equivalent on March 31, 1983, 36 days after the submission was received.
What is the product code of K830557?
The FDA product code is HLZ – Electrode, Corneal, a Class II (moderate risk) device regulated under 21 CFR 886.1220.