# Ensodata, Inc.

- Location (FDA's records): Madison, WI
- FDA decisions: 3 (2017–2024): 3 510(k) clearances
- Names in FDA's records: Ensodata, Inc. (2); Ensodata (1)
- Product codes: OLZ (2), MNR (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 5 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Advanced Brain Monitoring, Inc.: 1 (https://510kreport.com/company/advanced-brain-monitoring)
- Mycardio, LLC Dba Sleepimage.: 1 (https://510kreport.com/company/mycardio-dba-sleepimage)

## Firms that cite its devices most
- Brain Electrophysiology Laboratory Company, LLC: 1 (https://510kreport.com/company/brain-electrophysiology-laboratory)
- Onera B.V.: 1 (https://510kreport.com/company/onera)
- Neumetry Medical, Inc.: 1 (https://510kreport.com/company/neumetry-medical)
- Honeynaps Co., Ltd.: 1 (https://510kreport.com/company/honeynaps)

## Its most-cited devices
- K162627: EnsoSleep (2017), cited by 5

## Recent decisions
- K231355: Aurora (Feb 9, 2024)
- K210034: EnsoSleep (Jun 16, 2021)
- K162627: EnsoSleep (Mar 31, 2017)

Source page: https://510kreport.com/company/ensodata