← Back to catalogue

Aneroid Sphygmanometer With Stethoscope, Model Hs-50a

FDA 510(k)

Class II (US FDA 510(k))

510(k) K051021

by Shanghai Lord International Trade Co., Ltd.

Identifiers

510(k) Number
K051021 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)

The Aneroid Sphygmomanometer With Stethoscope, Model Hs-50a is a medical device used for measuring blood pressure. It is an aneroid sphygmomanometer, which means it uses a mechanical mechanism to measure pressure, and it comes with a stethoscope for listening to heart sounds.

The device is supplied as a single unit, including the sphygmomanometer and stethoscope, and is intended for use in a clinical setting. It has been assigned a product code of DXQ and has received FDA 510(k) clearance, with a decision date of 2005-06-20 and a k number of K051021.

Frequently asked questions

What is the Aneroid Sphygmomanometer With Stethoscope used for?

The Aneroid Sphygmomanometer With Stethoscope, Model HS-50A is used for measuring blood pressure and listening to heart sounds in a clinical setting.

Is the device supplied with a stethoscope?

Yes, the Aneroid Sphygmomanometer With Stethoscope, Model HS-50A is supplied as a single unit, including the sphygmomanometer and stethoscope.

What is the regulatory status of the device?

The Aneroid Sphygmomanometer With Stethoscope, Model HS-50A has received FDA 510(k) clearance with a k number of K051021.

What type of mechanism does the device use to measure pressure?

The Aneroid Sphygmomanometer With Stethoscope, Model HS-50A uses a mechanical mechanism to measure pressure, as it is an aneroid sphygmomanometer.

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: Aneroid Sphygmanometer With Stethoscope, Model Hs-50a, Aneroid Sphygmanometer With Stethoscope, Model Hs-50a, Aneroid Sphygmanometer With Stethoscope, Model Hs-50a, ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A 510(k) K051021 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Shanghai Lord International Trade Co., Ltd.

Sources (1)

  • FDA 510(k) K051021 24 fields · synced Oct 6, 2026