HEM-9210T
K-Number: K163235 · 2017-04-20
ApplicantOmron Healthcare, Inc.
Decision Date2017-04-20
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
HEM-9210T is a medical device manufactured by Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2017-04-20 under approval number K163235. 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 HEM-9210T?
HEM-9210T is a medical device that received FDA 510(k) clearance on 2017-04-20. It is manufactured by Omron Healthcare, Inc.. The 510(k) number is K163235.
When was HEM-9210T approved by the FDA?
HEM-9210T received FDA 510(k) clearance on 2017-04-20, under approval number K163235.
What company makes HEM-9210T?
HEM-9210T is manufactured by Omron Healthcare, Inc..
What is the FDA product code for HEM-9210T?
The FDA product code for HEM-9210T 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.