FDA 510(k) Application Details - K182503

Device Classification Name	Dc-Defibrillator, Low-Energy, (Including Paddles)   More FDA Info for this Device
510(K) Number	K182503
Device Name	Dc-Defibrillator, Low-Energy, (Including Paddles)
Applicant	Physio-Control, Inc. 11811 Willow Road NE Redmond, WA 98052 US Other 510(k) Applications for this Company
Contact	Chelsea Cullen Other 510(k) Applications for this Contact
Regulation Number	870.5300   More FDA Info for this Regulation Number
Classification Product Code	LDD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2018
Decision Date	06/03/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review