iTEMPSHIELD— 510(k) K232010

Substantially Equivalent

Aion Biosystems, Inc.

FDA 510(k) clearance K232010 for iTEMPSHIELD, Substantially Equivalent on 2023-08-04. Applicant: Aion Biosystems, Inc..

Clearance details

Applicant: Aion Biosystems, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2023-07-06
Decision date: 2023-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Darien, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.