Name: Predicase
Price: 199 USD

K-number	K152670
Device name	DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables
Applicant	Medos International SARL
Product code	GWM
Device class	Class II
Decision date	Jan 22, 2016
Decision	Substantially Equivalent
Regulation	882.1620

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Source

View the full FDA submission: accessdata.fda.gov

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DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables

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