Name: Predicase
Price: 199 USD

K-number	K223531
Device name	CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)
Applicant	GE Healthcare Finland Oy
Product code	MHX
Device class	Class II
Decision date	Apr 6, 2023
Decision	Substantially Equivalent
Regulation	870.1025

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Source

View the full FDA submission: accessdata.fda.gov

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CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)

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