Name: Predicase
Price: 199 USD

K-number	K191689
Device name	EleGARD Patient Positioning System
Applicant	Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio
Product code	FOA
Device class	Class I
Decision date	Feb 13, 2020
Decision	Substantially Equivalent
Regulation	880.6080

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Source

View the full FDA submission: accessdata.fda.gov

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EleGARD Patient Positioning System

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