GUS610 Blood pressure monitor

FDA 510(k) K222160 · Globalcare Medical Technology Co., Ltd.

Substantially Equivalent

510(k) numberK222160

Submission

Device name
GUS610 Blood pressure monitor
Applicant
Globalcare Medical Technology Co., Ltd.
Zhongshan City, CN
Received
July 20, 2022
Decision date
November 22, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DXN – System, Measurement, Blood-Pressure, Non-Invasive
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1130
Specialty
Cardiovascular

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K260693VicorderCS (VCS-SYS-1100)DXN · Traditional 80 Beats Medical GmbH06/16/2026SE

More from 80 Beats Medical GmbH

510(k)DeviceDecision
K253896TENS/EMS device (GUSE01)NUH · Traditional 03/04/2026SE
K250136Globalcare Blood Pressure Monitor (GUS610)DXN · Special 04/08/2025SE
K192633GUS831 Compressor NebulizerCAF · Traditional 05/01/2020SE
K192609Globalcare Blood Pressure MonitorDXN · Traditional 04/21/2020SE

Questions and answers

When was GUS610 Blood pressure monitor cleared by the FDA?

GUS610 Blood pressure monitor (K222160) received a 510(k) decision of Substantially Equivalent on November 22, 2022, 125 days after the submission was received.

What is the product code of K222160?

The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.