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510(k) K221901

Device
EleGARD
Applicant
AdvancedCPR Solutions LLC
510(k) number
K221901
Product code
FOA  
Decision
Substantially Equivalent (SESE)
Decision date
2022-07-29
Date received
2022-06-30
Regulation
880.6080
Classification name
Board, Cardiopulmonary
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Philip Faris
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
K191689EleGARD Patient Positioning SystemMinnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio2020-02-13
K811397ECAGillco, Inc.1981-07-02

Legacy Summary#

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FDA Review#

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