Upper Arm Blood Pressure Monitor
FDA 510(k) K191673 · Famidoc Technology Company Limited
510(k) numberK191673
Submission
- Device name
- Upper Arm Blood Pressure Monitor
- Applicant
- Famidoc Technology Company Limited
Dongguan, CN - Received
- June 24, 2019
- Decision date
- November 27, 2019
- 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 |
|---|---|---|
| K233192 | Wireless Smart ThermometerFLL · Traditional | 04/05/2024SE |
| K222887 | Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure MonitorDXN · Traditional | 04/10/2023SE |
| K212918 | Heat StimPlusNUH · Traditional | 12/13/2021SE |
| K130723 | FDES106 Mini Tens&Ems DEVICE,FDES106 Multi-Function Mini Tens&Ems DEVICE,FDES105 Pain…NGX · Traditional | 02/07/2014SE |
| K113010 | FDES100(TENS and EMS Stimulator, FDES102(ED402) TENS StimulatorIPF · Traditional | 12/21/2012SE |
| K113761 | Infrared ThermometerFLL · Traditional | 09/07/2012SE |
| K072641 | Digital Electronic Thermometer, Model: FDTH-V0-1 Thru 4.FLL · Traditional | 11/01/2007SE |
| K052849 | Infrared Thermometer, FDIR-V1FLL · Traditional | 10/26/2005SE |
Questions and answers
When was Upper Arm Blood Pressure Monitor cleared by the FDA?
Upper Arm Blood Pressure Monitor (K191673) received a 510(k) decision of Substantially Equivalent on November 27, 2019, 156 days after the submission was received.
What is the product code of K191673?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.