Name: Predicase
Price: 199 USD

K-number	K212355
Device name	Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
Applicant	Checkpoint Surgical
Product code	ETN
Device class	Class II
Decision date	Aug 26, 2021
Decision	Substantially Equivalent
Regulation	874.1820

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large

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