Name: Predicase
Price: 199 USD

K-number	K181292
Device name	PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor
Applicant	Cogentix Medical, Inc.
Product code	EOX
Device class	Class II
Decision date	Nov 15, 2018
Decision	Substantially Equivalent
Regulation	874.4710

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Source

View the full FDA submission: accessdata.fda.gov

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PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor

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

PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor