Automated Non-Invasive Pressure Module
FDA 510(k) K840909 · Gould, Inc.
510(k) numberK840909
Submission
- Device name
- Automated Non-Invasive Pressure Module
- Applicant
- Gould, Inc.
Mchenry, IL, US - Received
- February 29, 1984
- Decision date
- June 15, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K911935 | Cardiac Electrophysical Lead Selector, ModifiedDRR · Traditional | 07/22/1991SE |
| K861092 | Model SP1465 Cardiac Output ComputerDXG · Traditional | 08/18/1986SE |
| K860805 | Pressure Monitor Cath Models SP5325,SP5327,SP5337DQO · Traditional | 05/08/1986SE |
| K855145 | Model:Ta-Rose Resonant Overshoot EliminatorDRS · Traditional | 02/26/1986SE |
| K854403 | Model 2120 SpiroscreenBZG · Traditional | 01/14/1986SE |
| K851486 | Gould Disposable Transducer & Accessories-DtxDRS · Traditional | 10/17/1985SE |
| K850114 | C/Pes 9201, ECG Stress Testing SysDRT · Traditional | 02/22/1985SE |
| K850113 | C/Pes 9103, ECG Stress Testing SystemDRT · Traditional | 02/08/1985SE |
| K843555 | Cardiac Computer SP1445DXG · Traditional | 02/01/1985SE |
| K843969 | Model P23XL Physiological Pressure TransducerDXO · Traditional | 01/23/1985SE |
Questions and answers
When was Automated Non-Invasive Pressure Module cleared by the FDA?
Automated Non-Invasive Pressure Module (K840909) received a 510(k) decision of Substantially Equivalent on June 15, 1984, 107 days after the submission was received.
What is the product code of K840909?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.