FDA 510(k)

EleGARD Patient Positioning System

K-Number: K191689 · 2020-02-13

ApplicantMinnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio

Decision Date2020-02-13

Product CodeFOA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

EleGARD Patient Positioning System is the device name listed in this FDA 510(k) record. The listed applicant is Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio. It received FDA 510(k) clearance on 2020-02-13 under 510(k) 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. The listed applicant is Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio. The 510(k) number is K191689.

When did EleGARD Patient Positioning System receive FDA 510(k) clearance?

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

Who is the listed applicant for EleGARD Patient Positioning System?

The FDA 510(k) record lists Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: FOA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221901EleGARDAdvancedcpr Solutions, LLC

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.