Digital Automatic Wrist Blood Pressure Monitor MD3200
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151587 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 MD3200 is a non-invasive blood pressure monitoring device designed for measuring arterial blood pressure in human adults. It employs an inflatable cuff wrapped around the wrist to automatically determine systolic and diastolic pressure, as well as pulse rate, providing real-time readings and measurement history.
This device is intended for single-use or reusable clinical and home settings, depending on manufacturer guidelines. It is classified under FDA product code DXN and has received FDA 510(k) clearance and MDR authorization. The monitor operates without MRI restrictions and requires proper storage as specified by the manufacturer to maintain accuracy and functionality.
Frequently asked questions
Is the MD3200 designed for use in both clinical and home settings, and if so, how does that affect its intended use guidelines?
Yes, the MD3200 is intended for use in both clinical and home settings, as explicitly stated in its description. However, whether it is used as a single-use or reusable device depends on the manufacturer’s guidelines, which must be followed to ensure accuracy, hygiene, and functionality. Clinicians should refer to the manufacturer’s instructions for proper use and maintenance protocols in each setting.
What types of blood pressure measurements does the MD3200 provide, and how are these readings displayed?
The MD3200 automatically measures and displays systolic pressure, diastolic pressure, and pulse rate in real-time. It also stores measurement history, allowing users to track trends over time. The device uses an inflatable wrist cuff to obtain non-invasive readings.
Can the MD3200 be used in environments with MRI machines, and what limitations or considerations should be noted?
The MD3200 is explicitly stated to have no MRI restrictions, meaning it can be used in areas where MRI scans are performed without interference. However, standard electromagnetic interference precautions should still be followed, as with any electronic medical device, to ensure accurate readings and safety.
How should the MD3200 be stored to maintain its accuracy and functionality over time?
The manufacturer specifies that proper storage is required to maintain the MD3200’s accuracy and functionality, though exact storage conditions (e.g., temperature, humidity) are not detailed in the provided data. Users should follow the manufacturer’s guidelines, which likely include keeping the device in a clean, dry environment away from direct sunlight or extreme temperatures to prevent damage.
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. Sources consulted: Digital Automatic Wrist Blood Pressure Monitor MD3200, Digital Automatic Wrist Blood Pressure Monitor MD3200, Digital Automatic Wrist Blood Pressure Monitor MD3200 510 (k) K151587 ...
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 | K151587 | Class II | Active |
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Manufacturer
- Manufacturer
- Grandway Technology (shenzhen) Limited
Sources (2)
- FDA 510(k) K151587 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026