FORA P100 Blood Pressure Monitoring System
FDA 510(k) K182934 · Taidoc Technology Corporation
510(k) numberK182934
Submission
- Device name
- FORA P100 Blood Pressure Monitoring System
- Applicant
- Taidoc Technology Corporation
New Taipei City, TW - Received
- October 22, 2018
- Decision date
- February 12, 2019
- 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
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 |
|---|---|---|
| K221349 | XPER Technology PREMIUM Pro Blood Glucose Monitoring SystemPZI · Dual Track | 11/19/2024SE |
| K201037 | FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemNBW · Traditional | 06/16/2022SE |
| K200946 | Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)FLL · Traditional | 04/05/2022SE |
| K190579 | TD-4183 Blood Glucose Monitoring SystemNBW · Traditional | 06/04/2019SE |
| K180863 | FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorBTA · Traditional | 12/19/2018SE |
| K181675 | FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring SystemPTC · Traditional | 12/10/2018SE |
| K181588 | POPS! one Blood Glucose Monitoring SystemNBW · Traditional | 11/30/2018SE |
| K172733 | TD-1035 ThermometerFLL · Traditional | 10/22/2018SE |
| K173511 | ActiveCare TD-4121 Blood Glucose Monitoring SystemNBW · Special | 07/12/2018SE |
| K172221 | VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100MWI · Traditional | 06/06/2018SE |
Questions and answers
When was FORA P100 Blood Pressure Monitoring System cleared by the FDA?
FORA P100 Blood Pressure Monitoring System (K182934) received a 510(k) decision of Substantially Equivalent on February 12, 2019, 113 days after the submission was received.
What is the product code of K182934?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.