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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Board, Cardiopulmonary
510(k) Number K221901
Device Name EleGARD
Applicant
Advancedcpr Solutions, LLC
5201 Eden Ave., Suite 300
Edina,  MN  55436
Applicant Contact Philip Faris
Correspondent
ProMedic Consulting, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number880.6080
Classification Product Code
FOA  
Date Received06/30/2022
Decision Date 07/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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