Name: Predicase
Price: 199 USD

K-number	K162503
Device name	Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software
Applicant	Cardiac Insight, Inc.
Product code	DSH
Device class	Class II
Decision date	Mar 24, 2017
Decision	Substantially Equivalent
Regulation	870.2800

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Source

View the full FDA submission: accessdata.fda.gov

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Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software

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