Hidroxa SE30
K-Number: K241267 · 2024-10-17
ApplicantHidroxa Medical AB
Decision Date2024-10-17
Product CodeEGJ
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Hidroxa SE30 is a medical device manufactured by Hidroxa Medical AB. It received FDA 510(k) clearance on 2024-10-17 under approval number K241267. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Hidroxa SE30?
Hidroxa SE30 is a medical device that received FDA 510(k) clearance on 2024-10-17. It is manufactured by Hidroxa Medical AB. The 510(k) number is K241267.
When was Hidroxa SE30 approved by the FDA?
Hidroxa SE30 received FDA 510(k) clearance on 2024-10-17, under approval number K241267.
What company makes Hidroxa SE30?
Hidroxa SE30 is manufactured by Hidroxa Medical AB.
What is the FDA product code for Hidroxa SE30?
The FDA product code for Hidroxa SE30 is EGJ.
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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.