K-number	DEN170089
Device name	Curve Positive Airway Pressure System
Applicant	Fresca Medical
Product code	QBY
Device class	Class II
Decision date	Jun 5, 2018
Decision	Not Substantially Equivalent
Regulation	868.5273

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Source

View the full FDA submission: accessdata.fda.gov

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Curve Positive Airway Pressure System

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