Electronic Digital Blood Pressure Monitor
FDA 510(k) K882635 · Nihon Seimitsu Sokki Co., Ltd.
510(k) numberK882635
Submission
- Device name
- Electronic Digital Blood Pressure Monitor
- Applicant
- Nihon Seimitsu Sokki Co., Ltd.
Shibukawa-Shi, Gunma-Ken, JP - Received
- June 27, 1988
- Decision date
- November 9, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K112620 | Disital Blood Pressure MonitorDXN · Traditional | 08/02/2012SE |
| K112691 | Blood Pressure MonitorDXN · Traditional | 02/24/2012SE |
| K112690 | Blood Pressure MonitorDXN · Traditional | 02/24/2012SE |
| K093102 | Ambulatory Blood Pressure Monitor, Models FB-270 and DS-270DXN · Traditional | 06/03/2010SE |
| K080177 | Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PVDXN · Traditional | 05/09/2008SE |
| K071596 | Potable Air Massager Putifino, Model AM-7IRP · Traditional | 02/15/2008SE |
| K071384 | Modification to: Digital Blood Pressure Monitor, Model 1901DXN · Traditional | 10/09/2007SE |
| K061086 | DM-3000 Digital Blood Pressure MonitorDXN · Traditional | 08/10/2006SE |
| K050697 | Model DS-1901 Digital Blood Pressure MonitorDXN · Traditional | 03/25/2005SE |
| K040309 | Digital Blood Pressure Monitor, Model DS-1862DXN · Special | 02/24/2004SE |
Questions and answers
When was Electronic Digital Blood Pressure Monitor cleared by the FDA?
Electronic Digital Blood Pressure Monitor (K882635) received a 510(k) decision of Substantially Equivalent on November 9, 1988, 135 days after the submission was received.
What is the product code of K882635?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.