The following data is part of a premarket notification filed by Chongqing Kanghua Ruiming S&t Co., Ltd. with the FDA for Slm-1er, Slm-2er, Slm-3er.
| Device ID | K171877 |
| 510k Number | K171877 |
| Device Name: | SLM-1ER, SLM-2ER, SLM-3ER |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | Chongqing Kanghua Ruiming S&T Co., Ltd. No.5, Road1, Tongjiaxi Industrial Park, Beibei Chongqing, CN 400070 |
| Contact | Xi You |
| Correspondent | Xi You Chongqing Kanghua Ruiming S&T Co., Ltd. No.5, Road1, Tongjiaxi Industrial Park, Beibei Chongqing, CN 400070 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-23 |
| Decision Date | 2017-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06951214400039 | K171877 | 000 |
| 06951214400022 | K171877 | 000 |
| 06951214400015 | K171877 | 000 |