K-number	K222983
Device name	NeuroBlate Fusion-S Software V3.17
Applicant	Monteris Medical,
Product code	GEX
Device class	Class II
Decision date	Mar 15, 2023
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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NeuroBlate Fusion-S Software V3.17

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