CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor
FDA 510(k) K202757 · Contec Medical Systems Co.,Ltd
510(k) numberK202757
Submission
- Device name
- CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor
- Applicant
- Contec Medical Systems Co.,Ltd
Qinhuangdao, CN - Received
- September 21, 2020
- Decision date
- April 28, 2021
- 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 |
|---|---|---|
| K232893 | Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal…KNG · Traditional | 06/14/2024SE |
| K232895 | B-Ultrasound Diagnostic SystemIYO · Traditional | 05/03/2024SE |
| K232908 | Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…IYN · Traditional | 05/02/2024SE |
| K220245 | Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)KNG · Traditional | 09/28/2022SE |
| K201980 | Infrared ThermometerFLL · Traditional | 12/18/2020SE |
| K171360 | CONTEC ElectrocardiographDPS · Traditional | 01/22/2018SE |
| K170856 | CMS600P2 B-Ultrasound Diagnostic SystemIYO · Traditional | 11/17/2017SE |
| K170954 | Portable ECG MonitorDPS · Traditional | 05/30/2017SE |
| K152863 | Portable ECG MonitorDPS · Traditional | 06/22/2016SE |
| K141362 | Pulse Oximeter CMS50EWDQA · Traditional | 04/23/2015SE |
Questions and answers
When was CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor cleared by the FDA?
CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor (K202757) received a 510(k) decision of Substantially Equivalent on April 28, 2021, 219 days after the submission was received.
What is the product code of K202757?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.