Truly Automatic Blood Pressure Monitor, Model DB11
FDA 510(k) K081852 · Truly Instrument Limited
510(k) numberK081852
Submission
- Device name
- Truly Automatic Blood Pressure Monitor, Model DB11
- Applicant
- Truly Instrument Limited
Shanwei City, Guangdong, CN - Received
- June 30, 2008
- Decision date
- December 12, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K220276 | Infrared Thermometer TET-351FLL · Traditional | 02/17/2023SE |
| K192023 | Arm Blood Pressure MonitorDXN · Abbreviated | 12/23/2019SE |
| K170545 | Automatic Wrist Bluetooth Blood Pressure MonitorDXN · Abbreviated | 11/21/2017SE |
| K161846 | Automatic Arm Bluetooth Blood Pressure MonitorDXN · Abbreviated | 10/24/2016SE |
| K113083 | Truly Automatic Arm Blood Pressure MonitorDXN · Abbreviated | 01/19/2012SE |
| K113085 | Tryly Automatic Wrist Blood Pressure MonitorDXN · Abbreviated | 01/12/2012SE |
| K091434 | Truly Automatic Arm Blood Pressure MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M…DXN · Abbreviated | 09/04/2009SE |
| K091415 | Truly Automatic Wrist Blood Pressure Monitor, Model DW100,DW200…DXN · Abbreviated | 09/04/2009SE |
| K090564 | Truly Infrared Ear Thermometer, Model TET-350, TET-360, TET-370FLL · Abbreviated | 06/24/2009SE |
Questions and answers
When was Truly Automatic Blood Pressure Monitor, Model DB11 cleared by the FDA?
Truly Automatic Blood Pressure Monitor, Model DB11 (K081852) received a 510(k) decision of Substantially Equivalent on December 12, 2008, 165 days after the submission was received.
What is the product code of K081852?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.