The following data is part of a premarket notification filed by Shenzhen Jamr Medical Technology Co., Ltd with the FDA for Wrist Type Blood Pressure Monitor.
| Device ID | K220651 |
| 510k Number | K220651 |
| Device Name: | Wrist Type Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Shenzhen Jamr Medical Technology Co., Ltd A101-301,D101-201, Jamr Science & Technology Park, No. 2 Guiyuan Road, Guixiang Community, Shenzhen, CN 518100 |
| Contact | Luo Fusheng |
| Correspondent | Reanny Wang Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 2012#, Gebu Commercial Building, Hongxing Community, Songgang Street Shenzhen, CN 518000 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-07 |
| Decision Date | 2022-06-30 |