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FDA 510(k)

Digital Blood Pressure Monitor (Model: YB-800)

K-Number: K231478 · 2023-12-15

Decision Date2023-12-15
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Digital Blood Pressure Monitor (Model: YB-800) is the device name listed in this FDA 510(k) record. The listed applicant is Wenzhou Yosun Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K231478. 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 Digital Blood Pressure Monitor (Model: YB-800)?

Digital Blood Pressure Monitor (Model: YB-800) is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Wenzhou Yosun Medical Technology Co.,Ltd. The 510(k) number is K231478.

When did Digital Blood Pressure Monitor (Model: YB-800) receive FDA 510(k) clearance?

Digital Blood Pressure Monitor (Model: YB-800) received FDA 510(k) clearance on 2023-12-15, under 510(k) number K231478.

Who is the listed applicant for Digital Blood Pressure Monitor (Model: YB-800)?

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

What is the FDA product code for Digital Blood Pressure Monitor (Model: YB-800)?

The FDA product code for Digital Blood Pressure Monitor (Model: YB-800) is DXN.

Related Clinical Trials

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.

Other records listing Wenzhou Yosun Medical Technology 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.

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.