Digital Automatic Wrist Blood Pressure Monitor MD4300
K-Number: K171379 · 2018-04-10
Decision Date2018-04-10
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Digital Automatic Wrist Blood Pressure Monitor MD4300 is a medical device manufactured by Grandway Technology (Shenzhen) Limited. It received FDA 510(k) clearance on 2018-04-10 under approval number K171379. 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 MD4300?
Digital Automatic Wrist Blood Pressure Monitor MD4300 is a medical device that received FDA 510(k) clearance on 2018-04-10. It is manufactured by Grandway Technology (Shenzhen) Limited. The 510(k) number is K171379.
When was Digital Automatic Wrist Blood Pressure Monitor MD4300 approved by the FDA?
Digital Automatic Wrist Blood Pressure Monitor MD4300 received FDA 510(k) clearance on 2018-04-10, under approval number K171379.
What company makes Digital Automatic Wrist Blood Pressure Monitor MD4300?
Digital Automatic Wrist Blood Pressure Monitor MD4300 is manufactured by Grandway Technology (Shenzhen) Limited.
What is the FDA product code for Digital Automatic Wrist Blood Pressure Monitor MD4300?
The FDA product code for Digital Automatic Wrist Blood Pressure Monitor MD4300 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.