# Neurosigma, Inc.

- Location (FDA's records): Los Angeles, CA
- FDA decisions: 2 (2019–2024): 1 510(k) clearance and 1 De Novo grant
- Product codes: QGL (2)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 3 (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 that cite its devices most
- Bistos Co., Ltd.: 1 (https://510kreport.com/company/bistos)
- Nu Eyne Co., Ltd.: 1 (https://510kreport.com/company/nu-eyne)

## Its most-cited devices
- DEN180041: Monarch eTNS System (2019), cited by 3

## Recent decisions
- K233293: Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® (Jan 16, 2024)
- DEN180041: Monarch eTNS System (Apr 19, 2019)

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