K843196 is an FDA 510(k) clearance for the VISITEC EYE SPECULUM. This device is classified as a Specula, Ophthalmic (Class I - General Controls, product code HNC).
Submitted by Visitec Co. (Mchenry, US). The FDA issued a Cleared decision on October 5, 1984, 52 days after receiving the submission on August 14, 1984.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K843196 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 1984 |
| Decision Date | October 05, 1984 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HNC — Specula, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |