The following data is part of a premarket notification filed by Belun Technology Company Limited with the FDA for Belun Ring Blr-100x.
| Device ID | K211407 |
| 510k Number | K211407 |
| Device Name: | Belun Ring BLR-100X |
| Classification | Oximeter |
| Applicant | Belun Technology Company Limited Unit 218, 2/F, Core Building 2, No. 1 Science Park West Avenue, Hong Kong Science Park Sha Tin, CN |
| Contact | Leung Lap Wai Lydia |
| Correspondent | Leung Lap Wai Lydia Belun Technology Company Limited Unit 218, 2/F, Core Building 2, No. 1 Science Park West Avenue, Hong Kong Science Park Sha Tin, CN |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-06 |
| Decision Date | 2021-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04899959015090 | K211407 | 000 |
| 04899959015083 | K211407 | 000 |
| 04899959015076 | K211407 | 000 |
| 04899959015007 | K211407 | 000 |