FDA 510(k) Application Details - K190437

Device Classification Name	Tester, Defibrillator   More FDA Info for this Device
510(K) Number	K190437
Device Name	Tester, Defibrillator
Applicant	Netech Corporation 110 Toledo Street Farmingdale, NY 11735 US Other 510(k) Applications for this Company
Contact	Mohan Das Other 510(k) Applications for this Contact
Regulation Number	870.5325   More FDA Info for this Regulation Number
Classification Product Code	DRL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/22/2019
Decision Date	08/28/2019
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