K191314 is an FDA 510(k) clearance for the Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q. This device is classified as a Tonometer, Manual (Class II - Special Controls, product code HKY).
Submitted by Chongqing Sunkingdom Medical Instrument Co., Ltd. (Chongqing, CN). The FDA issued a Cleared decision on December 19, 2019, 218 days after receiving the submission on May 15, 2019.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.
| 510(k) Number | K191314 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2019 |
| Decision Date | December 19, 2019 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HKY - Tonometer, Manual |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1930 |