Name: Predicase
Price: 199 USD

K-number	K210992
Device name	Altech® Exhalation Valve (Single Limb and Dual Limb)
Applicant	Meditera Tibbi Malzeme San VE Tic AS
Product code	CBP
Device class	Class II
Decision date	Dec 23, 2021
Decision	Substantially Equivalent
Regulation	868.5870

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Source

View the full FDA submission: accessdata.fda.gov

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Altech® Exhalation Valve (Single Limb and Dual Limb)

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