The following data is part of a premarket notification filed by Chongqing Sunkingdom Medical Instrument Co Ltd with the FDA for Sunkingdom Slit Lamp.
| Device ID | K182306 |
| 510k Number | K182306 |
| Device Name: | Sunkingdom Slit Lamp |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | Chongqing Sunkingdom Medical Instrument Co Ltd 1012, Block A Of China Resource Center No.55 Of XieJiaWan,JiuLongPo Chongqing, CN 400050 |
| Contact | Joy Tse |
| Correspondent | Joy Tse Chongqing Sunkingdom Medical Instrument Co Ltd 1012, Block A Of China Resource Center No.55 Of XieJiaWan,JiuLongPo Chongqing, CN 400050 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-24 |
| Decision Date | 2018-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26973211070378 | K182306 | 000 |
| 26973211070330 | K182306 | 000 |