Blood Pressure Monitor
FDA 510(k) K162089 · Beijing Choice Electronic Technology Co., Ltd.
510(k) numberK162089
Submission
- Device name
- Blood Pressure Monitor
- Applicant
- Beijing Choice Electronic Technology Co., Ltd.
Beijing, CN - Received
- July 28, 2016
- Decision date
- February 10, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXN – System, Measurement, Blood-Pressure, Non-Invasive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1130
- Specialty
- Cardiovascular
Other 510(k)s with product code DXN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261929 | Upper Arm Blood pressure monitor (BP7155D)DXN · Special | OMRON Healthcare, Inc. | 09/10/2026SE |
| K254000 | Happy Health Blood Pressure MonitorDXN · Traditional | Happy Health, Inc. | 09/03/2026SE |
| K262658 | Automatic Digital Blood Pressure monitor (LD-526)DXN · Special | Honsun (Nantong) Co., Ltd. | 08/31/2026SE |
| K261394 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus…DXN · Traditional | JOYTECH Healthcare Co., Ltd. | 08/26/2026SE |
| K261061 | BP Go (BPP-855)DXN · Traditional | Wellvii, Inc. | 08/13/2026SE |
| K253425 | Arm-type Fully Automatic Digital Blood Pressure Monitor…DXN · Traditional | Joytech Healthcare Co. , Ltd. | 08/13/2026SE |
| K261136 | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)DXN · Traditional | Guangzhou Daxin Health Technology Co., Ltd. | 07/23/2026SE |
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)DXN · Traditional | Microlife Corporation | 07/23/2026SE |
| K253126 | Wrist Blood Pressure Monitor (XW-05)DXN · Traditional | Shenzhen Ziqing Medical Equipment Co., Ltd. | 06/18/2026SE |
| K260693 | VicorderCS (VCS-SYS-1100)DXN · Traditional | 80 Beats Medical GmbH | 06/16/2026SE |
More from 80 Beats Medical GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K232975 | Pulse Oximeter (MD300C228)DQA · Traditional | 06/21/2024SE |
| K230587 | Wrist Pulse OximeterDQA · Traditional | 11/30/2023SE |
| K230172 | Pulse OximeterDQA · Traditional | 08/12/2023SE |
| K220101 | Pulse OximeterDQA · Traditional | 03/08/2023SE |
| K221992 | Electronic Pulse StimulatorNUH · Traditional | 10/21/2022SE |
| K211400 | Pulse OximeterDQA · Traditional | 02/11/2022SE |
| K211752 | Infrared ThermometerFLL · Traditional | 01/21/2022SE |
| K211754 | Vital Signs MonitorMWI · Traditional | 11/15/2021SE |
| K181503 | Fingertip Pulse OximeterDQA · Traditional | 10/11/2018SE |
| K172366 | Wrist Pulse OximeterDQA · Traditional | 03/16/2018SE |
Questions and answers
When was Blood Pressure Monitor cleared by the FDA?
Blood Pressure Monitor (K162089) received a 510(k) decision of Substantially Equivalent on February 10, 2017, 197 days after the submission was received.
What is the product code of K162089?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.