Name: Predicase
Price: 199 USD

K-number	K173060
Device name	F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version
Applicant	Fisher and Paykel Healthcare Limited
Product code	CBK
Device class	Class II
Decision date	Jan 25, 2018
Decision	Substantially Equivalent
Regulation	868.5895

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Source

View the full FDA submission: accessdata.fda.gov

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F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version

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