FDA 510(k) Application Details - K200849

Device Classification Name	Dc-Defibrillator, Low-Energy, (Including Paddles)   More FDA Info for this Device
510(K) Number	K200849
Device Name	Dc-Defibrillator, Low-Energy, (Including Paddles)
Applicant	Remote Diagnostic Technologies, Ltd, a Philips Company Pavilion C2, Ashwood Park, Ashwood Way Basingstoke RG23 8BG GB Other 510(k) Applications for this Company
Contact	Martin Newman 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	03/31/2020
Decision Date	07/24/2020
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