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510(k) K191689

Device
EleGARD Patient Positioning System
Applicant
Minnesota Resuscitation Solutions, D.b.d AdvancedCPR Solutio
510(k) number
K191689
Product code
FOA  
Decision
Substantially Equivalent (SESE)
Decision date
2020-02-13
Date received
2019-06-25
Regulation
880.6080
Classification name
Board, Cardiopulmonary
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Philip Tetzlaff
Address
5201 Eden Ave., Suite 300 Edina MN US 55436 55436

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FOA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K221901EleGARDAdvancedcpr Solutions, LLC2022-07-29
K811397ECAGillco, Inc.1981-07-02

Legacy Summary#

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FDA Review#

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