Automoatic Blood Pressure Monitor, Models: Easy X 800 and 900 (R/L)
FDA 510(k) K092432 · Jawon Medical Co., Ltd.
510(k) numberK092432
Submission
- Device name
- Automoatic Blood Pressure Monitor, Models: Easy X 800 and 900 (R/L)
- Applicant
- Jawon Medical Co., Ltd.
Kyungsan-City, Kyungsan-Bukdo, KR - Received
- August 7, 2009
- Decision date
- October 9, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K140762 | Automatic Blood Pressure MonitorDXN · Traditional | 07/02/2015SE |
| K140045 | Body Composition AnalyzerMNW · Traditional | 02/18/2015SE |
| K092431 | Body Composition Analyzer, Model: Ioi 353MNW · Special | 10/08/2009SE |
| K072325 | Body Composition Analyzer, Easybody 202, 203, 205MNW · Traditional | 11/30/2007SE |
| K071884 | Body Composition Analyzer, Models: X-Scan Plus II, Gaia 359 Plus, Plusavis 333, Xbia…MNW · Special | 08/09/2007SE |
| K062462 | Non-Invasive Blood Pressure Monitor, Models FT-500R/L and FT-700R/LDXN · Traditional | 09/29/2006SE |
| K053556 | Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5MNW · Traditional | 08/31/2006SE |
| K013876 | Infrared Ear Thermometer, Model DX-707FLL · Traditional | 03/04/2002SE |
| K002722 | Digital Blood Pressure Monitor, Models HD-503 and HD-505DXN · Special | 09/11/2000SE |
| K000675 | Manual Digital Blood Pressure Monitor, Model HD-502DXN · Traditional | 03/14/2000SE |
Questions and answers
When was Automoatic Blood Pressure Monitor, Models: Easy X 800 and 900 (R/L) cleared by the FDA?
Automoatic Blood Pressure Monitor, Models: Easy X 800 and 900 (R/L) (K092432) received a 510(k) decision of Substantially Equivalent on October 9, 2009, 63 days after the submission was received.
What is the product code of K092432?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.