Electroretinograph
FDA 510(k) K760199 · Lkc Technologies, Inc.
510(k) numberK760199
Submission
- Device name
- Electroretinograph
- Applicant
- Lkc Technologies, Inc.
Mchenry, IL, US - Received
- July 7, 1976
- Decision date
- August 4, 1976
- 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 |
| K830557 | Erg-Jet ElectrodeHLZ · Traditional | Universo S.A. | 03/31/1983SE |
| 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 |
More from Life-Tech Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K142567 | RETeval Visual Electrodiagnostic DeviceGWE · Traditional | 05/19/2015SE |
| K914163 | Scoptopic Sensitivity TEST-1[SST-1]HLX · Traditional | 10/25/1991SE |
| K913962 | Anomaloscope Quadrant TEST-6HIW · Traditional | 10/23/1991SE |
| K875026 | Anomaloscope Plate Test - 5 [APT-5]HIT · Traditional | 02/05/1988SE |
| K874336 | Pattern Discrimination PerimeterHPT · Traditional | 01/12/1988SE |
| K820414 | Universal Testing & Analysis SystemsGWF · Traditional | 03/04/1982SE |
| K790109 | Telemetry, BiomedicalDRG · Traditional | 03/16/1979SE |
Questions and answers
When was Electroretinograph cleared by the FDA?
Electroretinograph (K760199) received a 510(k) decision of Substantially Equivalent on August 4, 1976, 28 days after the submission was received.
What is the product code of K760199?
The FDA product code is HLZ – Electrode, Corneal, a Class II (moderate risk) device regulated under 21 CFR 886.1220.