Digital Blood Pressure Monitor-Automatic Upper Arm Style
K-Number: K163606 · 2017-05-09
ApplicantShenzhen Combei Technology Co., Ltd.
Decision Date2017-05-09
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Digital Blood Pressure Monitor-Automatic Upper Arm Style is a medical device manufactured by Shenzhen Combei Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-05-09 under approval number K163606. 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 Digital Blood Pressure Monitor-Automatic Upper Arm Style?
Digital Blood Pressure Monitor-Automatic Upper Arm Style is a medical device that received FDA 510(k) clearance on 2017-05-09. It is manufactured by Shenzhen Combei Technology Co., Ltd.. The 510(k) number is K163606.
When was Digital Blood Pressure Monitor-Automatic Upper Arm Style approved by the FDA?
Digital Blood Pressure Monitor-Automatic Upper Arm Style received FDA 510(k) clearance on 2017-05-09, under approval number K163606.
What company makes Digital Blood Pressure Monitor-Automatic Upper Arm Style?
Digital Blood Pressure Monitor-Automatic Upper Arm Style is manufactured by Shenzhen Combei Technology Co., Ltd..
What is the FDA product code for Digital Blood Pressure Monitor-Automatic Upper Arm Style?
The FDA product code for Digital Blood Pressure Monitor-Automatic Upper Arm Style 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.