Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office (TWIN200).
FDA 510(k) K082357 · Microlife Intellectual Property GmbH
510(k) numberK082357
Submission
- Device name
- Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office (TWIN200).
- Applicant
- Microlife Intellectual Property GmbH
Great Neck, NY, US - Received
- August 18, 2008
- Decision date
- October 29, 2008
- 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 |
|---|---|---|
| K230075 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5KDXN · Traditional | 06/28/2023SE |
| K222979 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5WDXN · Traditional | 05/19/2023SE |
| K222153 | Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)DXN · Traditional | 02/03/2023SE |
| K211776 | Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)FLL · Traditional | 03/01/2022SE |
| K211288 | Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4BDXN · Traditional | 11/04/2021SE |
| K202729 | Microlife Upper Arm Automatic Digital Blood Pressure MonitorDXN · Traditional | 04/08/2021SE |
| K200738 | Microlife Upper Arm Automatic Digital Blood Pressure MonitorDXN · Traditional | 07/23/2020SE |
| K200297 | Microlife Upper Arm Automatic Digital Blood Pressure MonitorDXN · Traditional | 06/18/2020SE |
| K191829 | Microlife Non-Contact Infrared Forehead ThermometerFLL · Traditional | 02/13/2020SE |
| K183663 | Microlife Digital Infrared Ear ThermometerFLL · Special | 07/16/2019SE |
Questions and answers
When was Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office (TWIN200). cleared by the FDA?
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office (TWIN200). (K082357) received a 510(k) decision of Substantially Equivalent on October 29, 2008, 72 days after the submission was received.
What is the product code of K082357?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.