Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K170866 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 Scian Automatic Digital Blood Pressure Monitor is a device used to measure the systolic and diastolic blood pressure and pulse rate of an adult individual using a non-invasive technique. It is an automatic digital blood pressure monitor available in models LD-575, LD-576, and LD-579. The device uses an inflatable cuff wrapped around the upper arm to take measurements. It is designed for non-invasive measurement of blood pressure and pulse rate.
The Scian Automatic Digital Blood Pressure Monitor is supplied in models LD-575, LD-576, and LD-579. It has been authorized with an FDA 510K clearance. The device is manufactured by Honsun (Nantong) Co., Ltd. and is intended for use in measuring blood pressure and pulse rate in adult individuals.
Frequently asked questions
What is the Scian Automatic Digital Blood Pressure Monitor used for?
The Scian Automatic Digital Blood Pressure Monitor is used to measure the systolic and diastolic blood pressure and pulse rate of an adult individual using a non-invasive technique.
Is the Scian Automatic Digital Blood Pressure Monitor supplied in different models?
Yes, the Scian Automatic Digital Blood Pressure Monitor is supplied in models LD-575, LD-576, and LD-579.
How does the Scian Automatic Digital Blood Pressure Monitor take measurements?
The device uses an inflatable cuff wrapped around the upper arm to take measurements of blood pressure and pulse rate.
What is the regulatory status of the Scian Automatic Digital Blood Pressure Monitor?
The Scian Automatic Digital Blood Pressure Monitor has been authorized with an FDA 510K clearance, indicating it is substantially equivalent to a predicate device.
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: Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 ..., Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 ..., Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170866 | Class II | Active |
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Manufacturer
- Manufacturer
- HONSUN (NANTONG) Co., Ltd.
Sources (1)
- FDA 510(k) K170866 24 fields · synced Oct 6, 2026