Name: Predicase
Price: 199 USD

K-number	K242269
Device name	SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)
Applicant	Quanta Dialysis Technologies, Ltd.
Product code	ONW
Device class	Class II
Decision date	Nov 1, 2024
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-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)

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