BAROguard
K-Number: K223874 · 2023-08-15
ApplicantParagonix Technologies
Decision Date2023-08-15
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
BAROguard is a medical device manufactured by Paragonix Technologies. It received FDA 510(k) clearance on 2023-08-15 under approval number K223874. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BAROguard?
BAROguard is a medical device that received FDA 510(k) clearance on 2023-08-15. It is manufactured by Paragonix Technologies. The 510(k) number is K223874.
When was BAROguard approved by the FDA?
BAROguard received FDA 510(k) clearance on 2023-08-15, under approval number K223874.
What company makes BAROguard?
BAROguard is manufactured by Paragonix Technologies.
What is the FDA product code for BAROguard?
The FDA product code for BAROguard is KDN.
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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.