Blood Pressure Monitor Y30001
FDA 510(k)Class II (US FDA 510(k))
by Zhangzhou Easepal Medical Science And Technology Co., Ltd.
Identifiers
- 510(k) Number
- K213023 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 Blood Pressure Monitor Y30001 is a medical device designed for measuring and monitoring blood pressure in clinical and home settings. It falls under the category of sphygmomanometers, providing accurate readings of systolic and diastolic pressure through automated or manual inflation and deflation of a cuff. The device is intended for use by healthcare professionals and patients to assess cardiovascular health and detect hypertension or hypotension.
This device is supplied as a reusable or single-use model (as specified in its configuration) and is intended for use in both clinical and home environments. It is not classified as MRI-safe or MRI-conditional, and its sterility status depends on the specific model variant; some may require cleaning and disinfection between uses. The Y30001 is authorised under FDA 510(k) clearance (K213023) as substantially equivalent to a predicate device, adhering to regulatory standards for cardiovascular monitoring equipment. Storage conditions typically include protection from extreme temperatures and direct sunlight.
Frequently asked questions
What is the Y30001 Blood Pressure Monitor used for?
The Y30001 Blood Pressure Monitor is designed to measure and monitor systolic and diastolic blood pressure in both clinical and home settings. It helps healthcare professionals and patients assess cardiovascular health, detect hypertension or hypotension, and track changes over time. The device uses automated or manual inflation/deflation of a cuff to provide accurate readings, making it suitable for routine monitoring.
Is the Y30001 Blood Pressure Monitor reusable or single-use?
The Y30001 Blood Pressure Monitor can be supplied in either reusable or single-use configurations, depending on the specific model variant. Reusable models require cleaning and disinfection between uses, while single-use models are intended for one-time use only. The sterility status varies by variant, so check the manufacturer’s instructions for proper handling and disposal.
What are the storage requirements for the Y30001?
To maintain accuracy and functionality, the Y30001 Blood Pressure Monitor should be stored in a protected environment away from extreme temperatures and direct sunlight. Proper storage ensures the device remains reliable for its intended use in both clinical and home settings.
Does the Y30001 have any special safety considerations?
The Y30001 Blood Pressure Monitor is not classified as MRI-safe or MRI-conditional, meaning it should not be used near MRI machines. Additionally, reusable models require proper cleaning and disinfection between uses to prevent cross-contamination. Always follow manufacturer guidelines for safe operation.
How is the Y30001 regulated?
The Y30001 Blood Pressure Monitor holds FDA 510(k) clearance (K213023) as substantially equivalent to a predicate device, meeting regulatory standards for cardiovascular monitoring equipment. This clearance ensures the device adheres to safety and performance requirements for clinical and home use.
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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213023 | Class II | Active |
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Manufacturer
Sources (1)
- FDA 510(k) K213023 24 fields · synced Oct 5, 2026