ERG-JET ELECTRODE
FDA 510(k) clearance K830557 · decided 1983-03-31
Clearance details
- K-number
- K830557
- Device name
- ERG-JET ELECTRODE
- Applicant
- Universo S.A.
- Decision
- Substantially Equivalent
- Date received
- 1983-02-23
- Decision date
- 1983-03-31
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- HLZ
- Device class
- 2
- Regulation number
- 886.1220
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| RM Electrode (RMH 25-01) (K253586) | Retmap, Inc. | 2026-04-01 |
| RM Electrode (RMH 23-01) (K232273) | Retmap, Inc. | 2023-12-07 |
| TOMEY DTL ELECTRODE (K961805) | Tomey Corporation USA | 1997-05-09 |
| SOPHER AND BIERER OVUM FORCEPS (K926540) | Thomasville Medical Assoc. | 1994-02-25 |
| GOLDLENS(TM) (K913239) | Doran Instruments, Inc. | 1992-01-31 |
| DTL ELECTRODE (K844409) | Sauquoit Industries, Inc. | 1985-02-14 |
| GOLD FOIL ERG ELECTRODES (K820254) | Cadwell Laboratories, Inc. | 1982-04-09 |
| ERG-JET ELECTRODE (K813399) | Nicolet Biomedical Instruments | 1982-01-22 |
| MULAR GOLD LEAF ELECTRODE MODEL 7501 (K781476) | Life-Tech Instruments, Inc. | 1978-11-15 |
| ELECTRORETINOGRAPH (K760199) | Lkc Technologies, Inc. | 1976-08-04 |
Recalls involving this device
No recalls on record reference this clearance.