K-number	K223644
Device name	Neuronaute with IceCap 2 & IceCap 2 Small
Applicant	Bioserenity
Product code	GWQ
Device class	Class II
Decision date	Jan 12, 2023
Decision	Substantially Equivalent
Regulation	882.1400

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Source

View the full FDA submission: accessdata.fda.gov

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Neuronaute with IceCap 2 & IceCap 2 Small

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