Name: Predicase
Price: 199 USD

K-number	K190672
Device name	StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1
Applicant	Medtronic Navigation, Inc.
Product code	HAW
Device class	Class II
Decision date	Jul 31, 2019
Decision	Substantially Equivalent
Regulation	882.4560

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1

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