AION TempShield
K-Number: K250401 · 2025-03-14
ApplicantAion Biosystems, Inc.
Decision Date2025-03-14
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
AION TempShield is a medical device manufactured by Aion Biosystems, Inc.. It received FDA 510(k) clearance on 2025-03-14 under approval number K250401. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AION TempShield?
AION TempShield is a medical device that received FDA 510(k) clearance on 2025-03-14. It is manufactured by Aion Biosystems, Inc.. The 510(k) number is K250401.
When was AION TempShield approved by the FDA?
AION TempShield received FDA 510(k) clearance on 2025-03-14, under approval number K250401.
What company makes AION TempShield?
AION TempShield is manufactured by Aion Biosystems, Inc..
What is the FDA product code for AION TempShield?
The FDA product code for AION TempShield is FLL.
Other Devices by Aion Biosystems, Inc.
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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.