K232273 is an FDA 510(k) clearance for the RM Electrode (RMH 23-01). This device is classified as a Electrode, Corneal (Class II - Special Controls, product code HLZ).
Submitted by Retmap, Inc. (Chicago, US). The FDA issued a Cleared decision on December 7, 2023, 129 days after receiving the submission on July 31, 2023.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1220.
| 510(k) Number | K232273 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2023 |
| Decision Date | December 07, 2023 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HLZ - Electrode, Corneal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1220 |