FDA 510(k) Application Details - K182839

Device Classification Name	Pulse-Generator, Pacemaker, External   More FDA Info for this Device
510(K) Number	K182839
Device Name	Pulse-Generator, Pacemaker, External
Applicant	Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. Rm 201, Bldg No.2, Huahan Sci-tech Industrial Park, No.16 Jinniu West Rd Shenzhen 518000 CN Other 510(k) Applications for this Company
Contact	Stephy Pan Other 510(k) Applications for this Contact
Regulation Number	870.3600   More FDA Info for this Regulation Number
Classification Product Code	DTE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/2018
Decision Date	02/28/2019
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