Name: Predicase
Price: 199 USD

K-number	K222067
Device name	SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
Applicant	Quanta Dialysis Technologies, Ltd.
Product code	KDI
Device class	Class II
Decision date	Nov 10, 2022
Decision	Substantially Equivalent
Regulation	876.5860

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Source

View the full FDA submission: accessdata.fda.gov

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SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set

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