Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series
K-Number: K163113 · 2017-01-19
Decision Date2017-01-19
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series is a medical device manufactured by Grandway Technology (Shenzhen) Limited. It received FDA 510(k) clearance on 2017-01-19 under approval number K163113. 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 Automatic Wrist Blood Pressure Monitor SWBPM22 Series?
Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series is a medical device that received FDA 510(k) clearance on 2017-01-19. It is manufactured by Grandway Technology (Shenzhen) Limited. The 510(k) number is K163113.
When was Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series approved by the FDA?
Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series received FDA 510(k) clearance on 2017-01-19, under approval number K163113.
What company makes Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series?
Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series is manufactured by Grandway Technology (Shenzhen) Limited.
What is the FDA product code for Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series?
The FDA product code for Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series 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.