K812544 is an FDA 510(k) clearance for the RELIANCE OPHTHALMIC INSTRUMENT CONTROL. This device is classified as a Stand, Instrument, Ac-powered, Ophthalmic (Class I - General Controls, product code HMF).
Submitted by F. & F. Koenigkramer (Mchenry, US). The FDA issued a Cleared decision on September 21, 1981, 17 days after receiving the submission on September 4, 1981.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1860.
| 510(k) Number | K812544 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 1981 |
| Decision Date | September 21, 1981 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HMF — Stand, Instrument, Ac-powered, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1860 |