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FDA 510(k)

EleGARD Patient Positioning System

K-Number: K191689 · 2020-02-13

Decision Date2020-02-13
Product CodeFOA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EleGARD Patient Positioning System is a medical device manufactured by Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio. It received FDA 510(k) clearance on 2020-02-13 under approval number K191689. The device is classified under product code FOA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EleGARD Patient Positioning System?

EleGARD Patient Positioning System is a medical device that received FDA 510(k) clearance on 2020-02-13. It is manufactured by Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio. The 510(k) number is K191689.

When was EleGARD Patient Positioning System approved by the FDA?

EleGARD Patient Positioning System received FDA 510(k) clearance on 2020-02-13, under approval number K191689.

What company makes EleGARD Patient Positioning System?

EleGARD Patient Positioning System is manufactured by Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio.

What is the FDA product code for EleGARD Patient Positioning System?

The FDA product code for EleGARD Patient Positioning System is FOA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.