FDA 510(k) Application Details - K191689

Device Classification Name	Board, Cardiopulmonary   More FDA Info for this Device
510(K) Number	K191689
Device Name	Board, Cardiopulmonary
Applicant	Minnesota Resuscitation Solutions, d.b.d AdvancedCPR Solutio 5201 Eden Ave., Suite 300 Edina, MN 55436 US Other 510(k) Applications for this Company
Contact	Philip Tetzlaff Other 510(k) Applications for this Contact
Regulation Number	880.6080   More FDA Info for this Regulation Number
Classification Product Code	FOA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2019
Decision Date	02/13/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review