Cleared Traditional

YUWELL Electronic Blood Pressure Monitor

K221372 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Cardiovascular
Oct 2022
Decision
158d
Days
Class 2
Risk

About This 510(k) Submission

K221372 is an FDA 510(k) clearance for the YUWELL Electronic Blood Pressure Monitor, a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. (Danyang, CN). The FDA issued a Cleared decision on October 17, 2022, 158 days after receiving the submission on May 12, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K221372 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2022
Decision Date October 17, 2022
Days to Decision 158 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXN — System, Measurement, Blood-pressure, Non-invasive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1130

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