Cleared Traditional

GUS610 Blood pressure monitor

K222160 · Globalcare Medical Technology Co., Ltd. · Cardiovascular
Nov 2022
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K222160 is an FDA 510(k) clearance for the GUS610 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 November 22, 2022, 125 days after receiving the submission on July 20, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K222160 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 2022
Decision Date November 22, 2022
Days to Decision 125 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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