Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Board, Cardiopulmonary
510(k) Number K191689
Device Name EleGARD Patient Positioning System
Applicant
Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio
5201 Eden Ave., Suite 300
Edina,  MN  55436
Applicant Contact Philip Tetzlaff
Correspondent
Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number880.6080
Classification Product Code
FOA  
Subsequent Product Code
DRM  
Date Received06/25/2019
Decision Date 02/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-