FDA 510(k) Application Details - K183348

Device Classification Name	Aid, Cardiopulmonary Resuscitation   More FDA Info for this Device
510(K) Number	K183348
Device Name	Aid, Cardiopulmonary Resuscitation
Applicant	Laerdal Medical AS Tanke Svilandsgate 30 Stavanger 2007 NO Other 510(k) Applications for this Company
Contact	Mari Kaada Other 510(k) Applications for this Contact
Regulation Number	870.5200   More FDA Info for this Regulation Number
Classification Product Code	LIX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/2018
Decision Date	12/17/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review