Name: Predicase
Price: 199 USD

K-number	K090957
Device name	BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM
Applicant	I2s Micro Implantable Systems, LLC
Product code	GWL
Device class	Class II
Decision date	May 28, 2009
Decision	Substantially Equivalent
Regulation	882.1835

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Source

View the full FDA submission: accessdata.fda.gov

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BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM

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