Gold Foil Erg Electrodes
FDA 510(k) K820254 · Cadwell Laboratories, Inc.
510(k) numberK820254
Submission
- Device name
- Gold Foil Erg Electrodes
- Applicant
- Cadwell Laboratories, Inc.
Mchenry, IL, US - Received
- February 1, 1982
- Decision date
- April 9, 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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| K844409 | DTL ElectrodeHLZ · Traditional | Sauquoit Industries, Inc. | 02/14/1985SE |
| K830557 | Erg-Jet ElectrodeHLZ · Traditional | Universo S.A. | 03/31/1983SE |
| 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 |
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Questions and answers
When was Gold Foil Erg Electrodes cleared by the FDA?
Gold Foil Erg Electrodes (K820254) received a 510(k) decision of Substantially Equivalent on April 9, 1982, 67 days after the submission was received.
What is the product code of K820254?
The FDA product code is HLZ – Electrode, Corneal, a Class II (moderate risk) device regulated under 21 CFR 886.1220.