K-number	K080601
Device name	ERGO++ VERSION 1.7
Applicant	3D Line Medical Systems S.R.L.
Product code	MUJ
Device class	Class II
Decision date	Jun 6, 2008
Decision	Substantially Equivalent
Regulation	892.5050

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Source

View the full FDA submission: accessdata.fda.gov

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ERGO++ VERSION 1.7

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