EleGARD Patient Positioning System— 510(k) K191689

Name: FDA 510(k) clearance K191689
Creator: U.S. Food and Drug Administration
Published: 2020-02-13

Substantially Equivalent

Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio

FDA 510(k) clearance K191689 for EleGARD Patient Positioning System, Substantially Equivalent on 2020-02-13. Applicant: Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio. Device class: 1.

Clearance details

Applicant: Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio
Product code: Code FOA
Device class: Class 1
Regulation: 21 CFR 880.6080
Advisory panel: General Hospital
Date received: 2019-06-25
Decision date: 2020-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edina, MN, US

Download summary PDF View on FDA.gov ↗

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