# Eb Neuro S.P.A.

- Location (FDA's records): Indianpolis, IN
- FDA decisions: 13 (2001–2024): 13 510(k) clearances
- Product codes: GWL (8), MNR (1), IKN (1), OLV (1), OLT (1), GWF (1)
- Predicates its devices cite: 22 (13 its own); citations of its devices by later devices: 26 (13 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
- Nellcor Puritan Bennett, Inc.: 1 (https://510kreport.com/company/nellcor-puritan-bennett)
- Respironics, Inc.: 1 (https://510kreport.com/company/respironics)
- Biosound, Inc.: 1 (https://510kreport.com/company/biosound)
- Oxford Instruments, Plc.: 1 (https://510kreport.com/company/oxford-instruments)
- Lifelines, Ltd.: 1 (https://510kreport.com/company/lifelines)
- Bio-Logic Systems Corp.: 1 (https://510kreport.com/company/bio-logic-systems)
- Nicolet Biomedical, Inc.: 1 (https://510kreport.com/company/nicolet-biomedical)
- Grass-Telefactor Divison: 1 (https://510kreport.com/company/grass-telefactor-divison)

## Firms that cite its devices most
- Stellate Systems: 1 (https://510kreport.com/company/stellate-systems)
- Cadwell Industries, Inc.: 1 (https://510kreport.com/company/cadwell-industries)
- Lifelines, Ltd.: 1 (https://510kreport.com/company/lifelines)
- Teleemg, LLC USA: 1 (https://510kreport.com/company/teleemg-usa)
- I2s Micro Implantable Systems, LLC: 1 (https://510kreport.com/company/i2s-micro-implantable-systems)
- Braebon Medical Corp.: 1 (https://510kreport.com/company/braebon-medical)
- Advanced Brain Monitoring, Inc.: 1 (https://510kreport.com/company/advanced-brain-monitoring)
- Respironics Inc., Sleep & Home Respiratory Group: 1 (https://510kreport.com/company/respironics-sleep-home-respiratory-group)

## Its most-cited devices
- K003154: Mizar, Basis BE, Sandman Digital (2001), cited by 5
- K040113: Sandman SD20 Amplifier (2004), cited by 4
- K073415: Nemus System; Nemus PC Peripheral (2008), cited by 4
- K053606: BE Plus / Aura-LTM64 Amplifier (2006), cited by 3
- K061996: Sandman Pocket (2006), cited by 3
- K121996: BE Plus LTM Amplifier Gwi Amplifier (2012), cited by 2

## Recent decisions
- K242832: NExT Station; NExT Station Advanced (Dec 12, 2024)
- K242305: BE Plus PRO, Neurotravel LIGHT (Sep 4, 2024)
- K150220: STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast (Aug 19, 2015)
- K142064: Galileo NT (Feb 13, 2015)
- K133517: Nemus 2 System (Feb 26, 2014)
- K121996: BE Plus LTM Amplifier Gwi Amplifier (Aug 3, 2012)
- K093728: BE Micro, Trea (Apr 29, 2010)
- K073415: Nemus System; Nemus PC Peripheral (May 23, 2008)

Source page: https://510kreport.com/company/eb-neuro