# Aesku Systems GmbH&Co.Kg

- Location (FDA's records): Wendelsheim, DE
- FDA decisions: 1 (2016–2016): 1 510(k) clearance
- Product codes: DHN (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K153117: AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM (Jul 28, 2016)

Source page: https://510kreport.com/company/aesku-systems
