The following data is part of a premarket notification filed by Lotusnine Medical Limited with the FDA for Ra-t59 Wrist Blood Pressure Monitor.
| Device ID | K212312 |
| 510k Number | K212312 |
| Device Name: | RA-T59 Wrist Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | LotusNine Medical Limited No. 2, Ln. 223, Sec. 1, Taiping Rd., Tsaotun Township Nantou County, TW 524007 |
| Contact | Yating Chang |
| Correspondent | Yuhua Chen PuHsu Consulting Ltd. 7F., No.272, Jiankang Rd., Zhonghe Dist. New Taipei City, TW 235042 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-23 |
| Decision Date | 2022-01-27 |