Name: Predicase
Price: 199 USD

K-number	K161162
Device name	Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
Applicant	Ellipse A/S
Product code	GEX
Device class	Class II
Decision date	Sep 16, 2016
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra

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