Name: Predicase
Price: 199 USD

K-number	K234134
Device name	AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System
Applicant	Resmed Pty Ltd (Registration Number: 3004604967)
Product code	BZD
Device class	Class II
Decision date	Sep 24, 2024
Decision	Substantially Equivalent
Regulation	868.5905

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Source

View the full FDA submission: accessdata.fda.gov

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AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System

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