Cleared Special

Electronic Blood Pressure Monitor

K200939 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Cardiovascular
Aug 2020
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K200939 is an FDA 510(k) clearance for the 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 August 20, 2020, 134 days after receiving the submission on April 8, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K200939 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 2020
Decision Date August 20, 2020
Days to Decision 134 days
Submission Type Special
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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