Ambulatory Blood Pressure Monitoring System, Model SE-25M/25P
FDA 510(k) K003711 · Sein Electronics Co., Ltd.
510(k) numberK003711
Submission
- Device name
- Ambulatory Blood Pressure Monitoring System, Model SE-25M/25P
- Applicant
- Sein Electronics Co., Ltd.
Anyang-City, Kyunggi-Do, KR - Received
- December 1, 2000
- Decision date
- December 15, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
|---|---|---|
| K052108 | Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100NBW · Abbreviated | 12/07/2005SE |
| K042138 | Full Auto Wrist Digital Blood Pressure Monitor Model# SE-311DXN · Special | 08/24/2004SE |
| K042014 | Digital Blood Pressure Monitor, Models SE-9000, SE-9200 and SE-9400DXN · Special | 08/06/2004SE |
| K032927 | Full Auto Arm Digital Blood Pressure MonitorDXN · Traditional | 05/07/2004SE |
| K012054 | Full Auto Wrist Digital Blood Pressure Monitor, Model SE-312DXN · Traditional | 08/08/2001SE |
| K003282 | Full Auto Blood Pressure Monitor, Model SE-7700HDXN · Traditional | 11/01/2000SE |
| K991397 | Transcutaneous Electrical Nerve Stimulator SE-30 TENSGZJ · Traditional | 02/11/2000SE |
| K973078 | Wrist Blood Pressure Meter Model SE-330DPW · Traditional | 05/20/1999SE |
| K952827 | Full Auto Wrist Blood Pressure Meter Model SE-5000DXN · Traditional | 11/14/1996SE |
| K952826 | Full Auto Fuzzy Blood Pressure Meter Model SE-7000DXN · Traditional | 11/14/1996SE |
Questions and answers
When was Ambulatory Blood Pressure Monitoring System, Model SE-25M/25P cleared by the FDA?
Ambulatory Blood Pressure Monitoring System, Model SE-25M/25P (K003711) received a 510(k) decision of Substantially Equivalent on December 15, 2000, 14 days after the submission was received.
What is the product code of K003711?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.