Name: Predicase
Price: 199 USD

K-number	K060827
Device name	MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100
Applicant	Esaote, S.p.A.
Product code	IYN
Device class	Class II
Decision date	May 19, 2006
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100

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