Name: Predicase
Price: 199 USD

K-number	K191624
Device name	F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version
Applicant	Fisher & Paykel Healthcare Limited
Product code	MNT
Device class	Class II
Decision date	Mar 9, 2020
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 Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version

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