Name: Predicase
Price: 199 USD

K-number	K152301
Device name	Background Pattern Classification [BPc(TM)]
Applicant	Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Product code	OMA
Device class	Class II
Decision date	Jun 3, 2016
Decision	Substantially Equivalent
Regulation	882.1400

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Source

View the full FDA submission: accessdata.fda.gov

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Background Pattern Classification [BPc(TM)]

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