Digital Automatic Wrist Blood Pressure Monitor MD4300
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171379 FDA 510(k)
- FDA Product Code
- DXN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1130 FDA 510(k)
- Regulation Number
- 870.1130 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Digital Automatic Wrist Blood Pressure Monitor MD4300 is a non-invasive blood pressure measurement device designed for ambulatory use. It automatically inflates and deflates a cuff around the wrist to measure systolic and diastolic blood pressure, pulse rate, and sometimes additional cardiovascular metrics. This device falls under the category of automated sphygmomanometers, intended for clinical and home monitoring settings.
The MD4300 is supplied as a single-use or reusable device, depending on manufacturer guidelines, and is intended for use in both clinical and home environments. It complies with FDA 510(k) clearance under the traditional pathway and meets MDR requirements, ensuring regulatory adherence for medical-grade accuracy. The device is not MRI-safe and requires proper storage as per manufacturer instructions to maintain calibration and performance. Authorisations include FDA_510K (K171379) and MDR compliance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K171379 | Class II | Active |
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Manufacturer
- Manufacturer
- Grandway Technology (shenzhen) Limited
Sources (2)
- FDA 510(k) K171379 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026