Name: Predicase
Price: 199 USD

K-number	K190713
Device name	F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)
Applicant	Fisher & Paykel Healthcare, Ltd.
Product code	BZD
Device class	Class II
Decision date	Oct 11, 2019
Decision	Substantially Equivalent
Regulation	868.5905

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Source

View the full FDA submission: accessdata.fda.gov

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F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)

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