FDA 510(k)

iTEMPSHIELD

K-Number: K232010 · 2023-08-04

Decision Date2023-08-04

Product CodeFLL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

iTEMPSHIELD is a medical device manufactured by Aion Biosystems, Inc.. It received FDA 510(k) clearance on 2023-08-04 under approval number K232010. 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 iTEMPSHIELD?

iTEMPSHIELD is a medical device that received FDA 510(k) clearance on 2023-08-04. It is manufactured by Aion Biosystems, Inc.. The 510(k) number is K232010.

When was iTEMPSHIELD approved by the FDA?

iTEMPSHIELD received FDA 510(k) clearance on 2023-08-04, under approval number K232010.

What company makes iTEMPSHIELD?

iTEMPSHIELD is manufactured by Aion Biosystems, Inc..

What is the FDA product code for iTEMPSHIELD?

The FDA product code for iTEMPSHIELD is FLL.

Other Devices by Aion Biosystems, Inc.

K250401AION TempShield

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.