Blood-Pressure ECG Transmitter
FDA 510(k) K844310 · Instromedix, Inc.
510(k) numberK844310
Submission
- Device name
- Blood-Pressure ECG Transmitter
- Applicant
- Instromedix, Inc.
Beaverton, OR, US - Received
- November 6, 1984
- Decision date
- April 18, 1985
- 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 |
|---|---|---|
| K010945 | Heartcard, Model 5258DXH · Traditional | 06/12/2001SE |
| K964408 | Poseidon Cardiac Monitoring System (PCMS)DPS · Traditional | 07/23/1997SE |
| K964036 | Cardiomagic 2000 SoftwareDXH · Traditional | 07/18/1997SE |
| K955060 | Accelerated Transmission ProtocolDXH · Traditional | 04/08/1996SE |
| K951096 | Lifesigns Receiving Cener 2000 Transtelephonic ReceiverDXH · Traditional | 01/16/1996SE |
| K945476 | Hearthwatch Iii(Tm)DXH · Traditional | 11/09/1995SE |
| K950003 | Cardiomagic(R) Software EnhancementsDXH · Traditional | 10/31/1995SE |
| K944362 | Heartcard Cardiac Event MonitorDXH · Traditional | 09/07/1995SE |
| K943931 | Carryall EnhancementsDXH · Traditional | 04/04/1995SE |
| K935586 | PrinceDXH · Traditional | 11/08/1994SE |
Questions and answers
When was Blood-Pressure ECG Transmitter cleared by the FDA?
Blood-Pressure ECG Transmitter (K844310) received a 510(k) decision of Substantially Equivalent on April 18, 1985, 163 days after the submission was received.
What is the product code of K844310?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.