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Aneroid Sphygmomanometer

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K203620

by Wuxi Exanovo Medical Instrument Co., Ltd.

Identifiers

510(k) Number
K203620 FDA 510(k)
FDA Product Code
DXQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1120 FDA 510(k)
Regulation Number
870.1120 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

An aneroid sphygmomanometer is a blood pressure measurement device designed to non-invasively assess arterial blood pressure in adults and children. It operates by measuring the pressure exerted by blood against the arterial walls using a mercury-free, aneroid manometer and an inflatable cuff, providing a visual reading of systolic and diastolic pressure via a dial gauge.

The device is supplied as a reusable medical instrument, intended for use in clinical, home, or office settings. It requires calibration and maintenance to ensure accuracy, with no specified sterility requirements beyond standard hygiene practices. Compliance with FDA 510(k) clearance (K203620) and MDR authorisation confirms its regulatory standing, though MRI safety and specific cuff sizes (e.g., adult, pediatric) must be verified per manufacturer instructions.

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

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Wuxi Exanovo Medical Instrument Co., Ltd.

Sources (2)

  • FDA 510(k) K203620 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026