Cleared Special

Globalcare Blood Pressure Monitor (GUS610)

K250136 · Globalcare Medical Technology Co., Ltd. · Cardiovascular
Apr 2025
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K250136 is an FDA 510(k) clearance for the Globalcare Blood Pressure Monitor (GUS610), a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Globalcare Medical Technology Co., Ltd. (Guangdong, CN). The FDA issued a Cleared decision on April 8, 2025, 81 days after receiving the submission on January 17, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K250136 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 2025
Decision Date April 08, 2025
Days to Decision 81 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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