K921214 is an FDA 510(k) clearance for the OPHTHALMIC PROJECTOR. This device is classified as a Projector, Ophthalmic (Class I - General Controls, product code HOS).
Submitted by Luneau Ophtalmologie SA (Chartres Cedex, FR). The FDA issued a Cleared decision on June 11, 1992, 90 days after receiving the submission on March 13, 1992.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1680.
| 510(k) Number | K921214 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 1992 |
| Decision Date | June 11, 1992 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HOS — Projector, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1680 |