The following data is part of a premarket notification filed by Belun Technology Company Limited with the FDA for Belun Ring.
| Device ID | K180174 |
| 510k Number | K180174 |
| Device Name: | Belun Ring |
| Classification | Oximeter |
| Applicant | Belun Technology Company Limited Rm531B, Floor 5, Core Building 2, 1 Science Park West Avenue HK Science Park Sha Tin, HK |
| Contact | Leung Lap Wai Lydia |
| Correspondent | Leung Lap Wai Lydia Belun Technology Company Limited Rm531B, Floor 5, Core Building 2, 1 Science Park West Avenue HK Science Park Sha Tin, HK |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-22 |
| Decision Date | 2018-05-29 |
| Summary: | summary |