The following data is part of a premarket notification filed by Shenzhen Zhengkang Technology Co., Ltd. with the FDA for Upper Arm Blood Pressure Monitor.
| Device ID | K191894 |
| 510k Number | K191894 |
| Device Name: | Upper Arm Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ShenZhen ZhengKang Technology Co., Ltd. 3/F, Building A, No. 3 FuXing Yi Lane, HeHua Community, PingHu Street Shenzhen City, CN 518100 |
| Contact | Huayong Yang |
| Correspondent | Becky Chen Feiying Drug & Medical Consulting Technical Service Group B-3F 3005, Bldg.1, Southward Ruifeng Business Center, No 22 Guimiao Rd. Shenzhen City, CN 518100 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-15 |
| Decision Date | 2020-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06922119300151 | K191894 | 000 |
| 06922119300144 | K191894 | 000 |
| 06922119300137 | K191894 | 000 |
| 06922119300120 | K191894 | 000 |
| 06922119300915 | K191894 | 000 |