The following data is part of a premarket notification filed by Shenzhen Finicare Co., Ltd. with the FDA for Upper Arm Electronic Blood Pressure Monitor(model Fc-bp100,fc-bp101,fc-bp102,fc-bp110,fc-bp111,fc-bp112).
| Device ID | K220113 |
| 510k Number | K220113 |
| Device Name: | Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112) |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Shenzhen Finicare Co., Ltd. 201, No.50, The 3rd Industrial Park, Houting Community, Shajing Street, Bao'an District Shenzhen, CN 518104 |
| Contact | Chao Li |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Shanghai, CN 200120 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-14 |
| Decision Date | 2022-05-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971522820329 | K220113 | 000 |
| 06971522820404 | K220113 | 000 |
| 06971522820411 | K220113 | 000 |
| 06971522820244 | K220113 | 000 |
| 06971522820251 | K220113 | 000 |
| 06971522820268 | K220113 | 000 |
| 06971522820275 | K220113 | 000 |
| 06971522820282 | K220113 | 000 |
| 06971522820299 | K220113 | 000 |
| 06971522820305 | K220113 | 000 |
| 06971522820312 | K220113 | 000 |
| 06971522820497 | K220113 | 000 |