Name: Predicase
Price: 199 USD

K-number	K201809
Device name	AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory
Applicant	Baxter Healthcare Corportation
Product code	KDI
Device class	Class II
Decision date	Mar 10, 2021
Decision	Substantially Equivalent
Regulation	876.5860

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Source

View the full FDA submission: accessdata.fda.gov

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AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory

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