FDA 510(k)

Анатомический тонометр с стетоскопом, QL-50, Анатомический тонометр, QL-20, Анатомический тонометр, QL-201

Номер K: K221857 · 2022-10-13

ЗаявительZhejiang Lude Technology Development Co., Ltd.

Дата решения2022-10-13

Код продуктаDXQ

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: DXQ)

K254287Medline Reusable Blood Pressure CuffMedline Industries, LP K260747YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffNihon Kohden Corporation K253089NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)Shenzhen Best Electronics Co., Ltd.K253964Disposable Neonatal NIBP Cuff (U1681S-C51N)Unimed Medical Supplies, Inc.K251745Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)Baxter Healthcare Corporation K250765AViTA Рукавный Тип Монитора Давления КровиAvita Corporation

Официальный источник

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