Name: Predicase
Price: 199 USD

K-number	K061974
Device name	GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT
Applicant	Instrumentation Laboratory CO
Product code	CHL
Device class	Class II
Decision date	Sep 15, 2006
Decision	Substantially Equivalent
Regulation	862.1120

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Source

View the full FDA submission: accessdata.fda.gov

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GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT

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