The following data is part of a premarket notification filed by Chongqing Sunkingdom Medical Instrument Co., Ltd with the FDA for Sunkingdom Applanation Tonometer Sk-r, Sk-t, Sk-q.
| Device ID | K191314 |
| 510k Number | K191314 |
| Device Name: | Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q |
| Classification | Tonometer, Manual |
| Applicant | Chongqing Sunkingdom Medical Instrument Co., Ltd 1012, Block A Of China Resource Center No.55 Of XieJiaWan JiuLongPo Chongqing, CN 400050 |
| Contact | Shulin Guo |
| Correspondent | Shulin Guo Chongqing Sunkingdom Medical Instrument Co., Ltd 1012, Block A Of China Resource Center No.55 Of XieJiaWan JiuLongPo Chongqing, CN 400050 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-15 |
| Decision Date | 2019-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26973211070491 | K191314 | 000 |
| 26973211070453 | K191314 | 000 |
| 26973211070415 | K191314 | 000 |