iTEMPSHIELD
K-Number: K232010 · 2023-08-04
Device Summary
Frequently Asked Questions
What is the iTEMPSHIELD?
iTEMPSHIELD is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is Aion Biosystems, Inc.. The 510(k) number is K232010.
When did iTEMPSHIELD receive FDA 510(k) clearance?
iTEMPSHIELD received FDA 510(k) clearance on 2023-08-04, under 510(k) number K232010.
Who is the listed applicant for iTEMPSHIELD?
The FDA 510(k) record lists Aion Biosystems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for iTEMPSHIELD?
The FDA product code for iTEMPSHIELD is FLL.
Other records listing Aion Biosystems, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: FLL)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.