Ambulatory Bllod Pressure Monitor, Electronic Sphygmomanometer,
FDA 510(k) K110156 · Contec Medical System Co., Ltd.
510(k) numberK110156
Submission
- Device name
- Ambulatory Bllod Pressure Monitor, Electronic Sphygmomanometer,
- Applicant
- Contec Medical System Co., Ltd.
Shanghai, CN - Received
- January 19, 2011
- Decision date
- July 27, 2011
- 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 |
|---|---|---|
| K180837 | CONTEC Oxygen ConcentratorCAW · Traditional | 01/10/2019SE |
| K131900 | Contec ElectrocardiographDPS · Traditional | 03/05/2014SE |
| K101273 | Dynamic ECG System Model TLC5000MLO · Traditional | 09/30/2011SE |
| K101692 | Patient MonitorMHX · Traditional | 06/28/2011SE |
| K110774 | Electronic SphygmomanometerDXN · Traditional | 05/13/2011SE |
| K101127 | Patient Monitor, Model PM50MWI · Traditional | 06/11/2010SE |
| K090936 | Single-Channel Handheld Electrocardiograph, Model ECG80ADPS · Traditional | 08/25/2009SE |
| K090671 | Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DDQA · Traditional | 06/11/2009SE |
| K082480 | Contec Pocket Fetal DopplerKNG · Traditional | 02/25/2009SE |
| K082641 | Fingertip Pulse Oximeter, Models CMS-50D, CMS-50L, CMS-50DLDQA · Special | 11/10/2008SE |
Questions and answers
When was Ambulatory Bllod Pressure Monitor, Electronic Sphygmomanometer, cleared by the FDA?
Ambulatory Bllod Pressure Monitor, Electronic Sphygmomanometer, (K110156) received a 510(k) decision of Substantially Equivalent on July 27, 2011, 189 days after the submission was received.
What is the product code of K110156?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.