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FDA 510(k)

YUWELL Electronic Blood Pressure Monitor

K-Number: K221372 · 2022-10-17

Decision Date2022-10-17
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

YUWELL Electronic Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. It received FDA 510(k) clearance on 2022-10-17 under 510(k) number K221372. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the YUWELL Electronic Blood Pressure Monitor?

YUWELL Electronic Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2022-10-17. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K221372.

When did YUWELL Electronic Blood Pressure Monitor receive FDA 510(k) clearance?

YUWELL Electronic Blood Pressure Monitor received FDA 510(k) clearance on 2022-10-17, under 510(k) number K221372.

Who is the listed applicant for YUWELL Electronic Blood Pressure Monitor?

The FDA 510(k) record lists Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for YUWELL Electronic Blood Pressure Monitor?

The FDA product code for YUWELL Electronic Blood Pressure Monitor is DXN.

Other records listing Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. as applicant

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.

View all 13 devices →

Related Devices (Code: DXN)

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.

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.