Name: Predicase
Price: 199 USD

K-number	K200734
Device name	Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
Applicant	Sirius Medical Systems B.V.
Product code	PBY
Device class	Class II
Decision date	Feb 24, 2021
Decision	Substantially Equivalent
Regulation	878.4300

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Source

View the full FDA submission: accessdata.fda.gov

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Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit

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