510(k) K232273
- Device
- RM Electrode (RMH 23-01)
- Applicant
- Retmap, Inc.
- 510(k) number
- K232273
- Product code
- HLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-07
- Date received
- 2023-07-31
- Regulation
- 886.1220
- Classification name
- Electrode, Corneal
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Shresta Patangay
- Address
- 832 W Superior St., Suite 202 Chicago IL US 60642 60642
FDA Registration Numbers#
- 3033274216
- 8043792
- 1221363
- 3004072823
- 2183828
Source Documents#
Other 510(k) Records For Product Code HLZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253586 | RM Electrode (RMH 25-01) | Retmap, Inc. | 2026-04-01 |
| K961805 | TOMEY DTL ELECTRODE | Tomey Corporation USA | 1997-05-09 |
| K926540 | SOPHER AND BIERER OVUM FORCEPS | Thomasville Medical Assoc. | 1994-02-25 |
| K913239 | GOLDLENS(TM) | Doran Instruments, Inc. | 1992-01-31 |
| K844409 | DTL ELECTRODE | Sauquoit Industries, Inc. | 1985-02-14 |
| K830557 | ERG-JET ELECTRODE | Universo S.A. | 1983-03-31 |
| K820254 | GOLD FOIL ERG ELECTRODES | Cadwell Laboratories, Inc. | 1982-04-09 |
| K813399 | ERG-JET ELECTRODE | Nicolet Biomedical Instruments | 1982-01-22 |
| K781476 | MULAR GOLD LEAF ELECTRODE MODEL 7501 | Life-Tech Instruments, Inc. | 1978-11-15 |
| K760199 | ELECTRORETINOGRAPH | Lkc Technologies, Inc. | 1976-08-04 |