Name: Predicase
Price: 199 USD

K-number	K241943
Device name	Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask
Applicant	Sleepnet Corporation
Product code	CBK
Device class	Class II
Decision date	Aug 28, 2024
Decision	Substantially Equivalent
Regulation	868.5895

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Source

View the full FDA submission: accessdata.fda.gov

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Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask

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