Klarity Bolus
K-Number: K202747 · 2021-05-14
Decision Date2021-05-14
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Klarity Bolus is a medical device manufactured by Klarity Medical & Equipment (GZ) Co., Ltd.. It received FDA 510(k) clearance on 2021-05-14 under approval number K202747. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Klarity Bolus?
Klarity Bolus is a medical device that received FDA 510(k) clearance on 2021-05-14. It is manufactured by Klarity Medical & Equipment (GZ) Co., Ltd.. The 510(k) number is K202747.
When was Klarity Bolus approved by the FDA?
Klarity Bolus received FDA 510(k) clearance on 2021-05-14, under approval number K202747.
What company makes Klarity Bolus?
Klarity Bolus is manufactured by Klarity Medical & Equipment (GZ) Co., Ltd..
What is the FDA product code for Klarity Bolus?
The FDA product code for Klarity Bolus is IYE.
Other Devices by Klarity Medical & Equipment (GZ) Co., Ltd.
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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.