Wrist Type Blood Pressure Monitor
K-Number: K200346 · 2020-12-17
ApplicantAvita Corporation
Decision Date2020-12-17
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Wrist Type Blood Pressure Monitor is a medical device manufactured by Avita Corporation. It received FDA 510(k) clearance on 2020-12-17 under approval number K200346. 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 Wrist Type Blood Pressure Monitor?
Wrist Type Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2020-12-17. It is manufactured by Avita Corporation. The 510(k) number is K200346.
When was Wrist Type Blood Pressure Monitor approved by the FDA?
Wrist Type Blood Pressure Monitor received FDA 510(k) clearance on 2020-12-17, under approval number K200346.
What company makes Wrist Type Blood Pressure Monitor?
Wrist Type Blood Pressure Monitor is manufactured by Avita Corporation.
What is the FDA product code for Wrist Type Blood Pressure Monitor?
The FDA product code for Wrist Type 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.