K-number	K233415
Device name	DELTAWAVE Nasal Pillows System
Applicant	Remsleep Holdings
Product code	BZD
Device class	Class II
Decision date	Jul 2, 2024
Decision	Substantially Equivalent
Regulation	868.5905

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Source

View the full FDA submission: accessdata.fda.gov

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DELTAWAVE Nasal Pillows System

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