Name: Predicase
Price: 199 USD

K-number	K233293
Device name	Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®
Applicant	Neurosigma, Inc.
Product code	QGL
Device class	Class II
Decision date	Jan 16, 2024
Decision	Substantially Equivalent
Regulation	882.5898

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Source

View the full FDA submission: accessdata.fda.gov

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Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®

Everything you need for a 510(k) submission. Nothing you don't.