Name: Predicase
Price: 199 USD

K-number	K212216
Device name	Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set
Applicant	Baxter Healthcare Corporation
Product code	KDI
Device class	Class II
Decision date	Apr 1, 2022
Decision	Substantially Equivalent
Regulation	876.5860

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set

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