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FDA 510(k)

Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201

K-Number: K221857 · 2022-10-13

ApplicantZhejiang Lude Technology Development Co., Ltd.
Decision Date2022-10-13
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: DXQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254287Medline Reusable Blood Pressure CuffMedline Industries, LPK260747YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffNihon Kohden CorporationK253089NIBP 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 CorporationK250765AViTA Arm Type Blood Pressure Monitor CuffAvita Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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