Name: Predicase
Price: 199 USD

K-number	K140387
Device name	Burn Resuscitation Decision Support System - Clinical (BRDSS-C)
Applicant	The Surgeon General, Department of the Army
Product code	PDT
Device class	Class II
Decision date	Dec 23, 2014
Decision	Substantially Equivalent
Regulation	868.1890

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Source

View the full FDA submission: accessdata.fda.gov

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Burn Resuscitation Decision Support System - Clinical (BRDSS-C)

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