GUS610 Blood pressure monitor
K-Number: K222160 · 2022-11-22
Decision Date2022-11-22
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
GUS610 Blood pressure monitor is a medical device manufactured by Globalcare Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-22 under approval number K222160. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GUS610 Blood pressure monitor?
GUS610 Blood pressure monitor is a medical device that received FDA 510(k) clearance on 2022-11-22. It is manufactured by Globalcare Medical Technology Co., Ltd.. The 510(k) number is K222160.
When was GUS610 Blood pressure monitor approved by the FDA?
GUS610 Blood pressure monitor received FDA 510(k) clearance on 2022-11-22, under approval number K222160.
What company makes GUS610 Blood pressure monitor?
GUS610 Blood pressure monitor is manufactured by Globalcare Medical Technology Co., Ltd..
What is the FDA product code for GUS610 Blood pressure monitor?
The FDA product code for GUS610 Blood pressure monitor is DXN.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.