Wrist Blood Pressure Monitor Model BP4350
K-Number: K182166 · 2018-11-08
ApplicantOmron Healthcare, Inc.
Decision Date2018-11-08
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Wrist Blood Pressure Monitor Model BP4350 is a medical device manufactured by Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2018-11-08 under approval number K182166. 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 Blood Pressure Monitor Model BP4350?
Wrist Blood Pressure Monitor Model BP4350 is a medical device that received FDA 510(k) clearance on 2018-11-08. It is manufactured by Omron Healthcare, Inc.. The 510(k) number is K182166.
When was Wrist Blood Pressure Monitor Model BP4350 approved by the FDA?
Wrist Blood Pressure Monitor Model BP4350 received FDA 510(k) clearance on 2018-11-08, under approval number K182166.
What company makes Wrist Blood Pressure Monitor Model BP4350?
Wrist Blood Pressure Monitor Model BP4350 is manufactured by Omron Healthcare, Inc..
What is the FDA product code for Wrist Blood Pressure Monitor Model BP4350?
The FDA product code for Wrist Blood Pressure Monitor Model BP4350 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.