Evolv Model BP7000 Upper Arm Blood Pressure Monitor
K-Number: K162092 · 2016-11-22
ApplicantOmron Healthcare, Inc.
Decision Date2016-11-22
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Evolv Model BP7000 Upper Arm Blood Pressure Monitor is a medical device manufactured by Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2016-11-22 under approval number K162092. 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 Evolv Model BP7000 Upper Arm Blood Pressure Monitor?
Evolv Model BP7000 Upper Arm Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2016-11-22. It is manufactured by Omron Healthcare, Inc.. The 510(k) number is K162092.
When was Evolv Model BP7000 Upper Arm Blood Pressure Monitor approved by the FDA?
Evolv Model BP7000 Upper Arm Blood Pressure Monitor received FDA 510(k) clearance on 2016-11-22, under approval number K162092.
What company makes Evolv Model BP7000 Upper Arm Blood Pressure Monitor?
Evolv Model BP7000 Upper Arm Blood Pressure Monitor is manufactured by Omron Healthcare, Inc..
What is the FDA product code for Evolv Model BP7000 Upper Arm Blood Pressure Monitor?
The FDA product code for Evolv Model BP7000 Upper Arm 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.