Name: Predicase
Price: 199 USD

K-number	K180902
Device name	MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly
Applicant	Medipines Corporation
Product code	CCK
Device class	Class II
Decision date	Jan 11, 2019
Decision	Substantially Equivalent
Regulation	868.1400

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Source

View the full FDA submission: accessdata.fda.gov

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MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly

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