Cleared Traditional

Globalcare Blood Pressure Monitor

K192609 · Globalcare Medical Technology Co., Ltd. · Cardiovascular
Apr 2020
Decision
214d
Days
Class 2
Risk

About This 510(k) Submission

K192609 is an FDA 510(k) clearance for the Globalcare Blood Pressure Monitor, a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Globalcare Medical Technology Co., Ltd. (Zhongshan City, CN). The FDA issued a Cleared decision on April 21, 2020, 214 days after receiving the submission on September 20, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K192609 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2019
Decision Date April 21, 2020
Days to Decision 214 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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