Electro Sensor Complex Software (Es Complex Software)
FDA 510(k) K113264 · Ld Technology, LLC
510(k) numberK113264
Submission
- Device name
- Electro Sensor Complex Software (Es Complex Software)
- Applicant
- Ld Technology, LLC
Miami, FL, US - Received
- November 4, 2011
- Decision date
- March 2, 2012
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K200287 | BP-BT KioskDXN · Traditional | 05/15/2020SE |
| K200141 | Oxi-W SystemMWI · Special | 04/27/2020SE |
| K173696 | TBL-ABI SystemJOM · Special | 12/19/2017SE |
| K160956 | LD-Oxi systemMWI · Special | 07/06/2016SE |
| K152216 | SudoCGZO · Special | 09/24/2015SE |
| K143152 | TM-ABI systemJOM · Traditional | 07/22/2015SE |
| K140412 | ANS1 SoftwareDXN · Special | 05/22/2014SE |
| K131568 | Sudo PathGZO · Special | 06/28/2013SE |
| K130056 | Patient MonitorMWI · Traditional | 04/11/2013SE |
| K103026 | Electro Sensor -Body CompositionMNW · Traditional | 03/29/2011SE |
Questions and answers
When was Electro Sensor Complex Software (Es Complex Software) cleared by the FDA?
Electro Sensor Complex Software (Es Complex Software) (K113264) received a 510(k) decision of Substantially Equivalent on March 2, 2012, 119 days after the submission was received.
What is the product code of K113264?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.