FDA 510(k)

Esfigmomanômetro Aneroid com estetoscópio, QL-50, Esfigmomanômetro, QL-20, Esfigmomanômetro, QL-201

Número K: K221857 · 2022-10-13

RequerenteZhejiang Lude Technology Development Co., Ltd.

Data da decisão2022-10-13

Código do produtoDXQ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201 is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Lude Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2022-10-13 under 510(k) number K221857. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201?

Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201 is a medical device that received FDA 510(k) clearance on 2022-10-13. The listed applicant is Zhejiang Lude Technology Development Co., Ltd.. The 510(k) number is K221857.

When did Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201 receive FDA 510(k) clearance?

Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201 received FDA 510(k) clearance on 2022-10-13, under 510(k) number K221857.

Who is the listed applicant for Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201?

The FDA 510(k) record lists Zhejiang Lude Technology Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201?

The FDA product code for Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201 is DXQ.

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