Dinamap Model 855
FDA 510(k) K791159 · Applied Medical Research
510(k) numberK791159
Submission
- Device name
- Dinamap Model 855
- Applicant
- Applied Medical Research
Mchenry, IL, US - Received
- June 21, 1979
- Decision date
- July 30, 1979
- 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 |
|---|---|---|
| K800025 | Dinamap Research Monitor 1245DXN · Traditional | 02/01/1980SE |
| K791580 | Cerebral Function Monitor 870OMA · Traditional | 09/04/1979SE |
| K790322 | Optional Accessory Foot Switch Model 100EBW · Traditional | 05/14/1979SE |
| K790328 | Model 1051, MonitorDXN · Traditional | 03/02/1979SE |
| K782073 | Dinamap Models 1160 and 1165DSK · Traditional | 02/23/1979SE |
| K781064 | Dinamap Model 848DSK · Traditional | 09/07/1978SE |
| K781053 | Dinamap Model 846DSK · Traditional | 09/07/1978SE |
| K781311 | Electrode, Needle, CFMGXZ · Traditional | 08/21/1978SE |
| K780754 | Neonatal MonitorDXN · Traditional | 06/14/1978SE |
| K780759 | Model 902 StandFSH · Traditional | 05/19/1978SE |
Questions and answers
When was Dinamap Model 855 cleared by the FDA?
Dinamap Model 855 (K791159) received a 510(k) decision of Substantially Equivalent on July 30, 1979, 39 days after the submission was received.
What is the product code of K791159?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.