FDA 510(k) Application Details - K162665

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K162665
Device Name	Electrocardiograph
Applicant	MITAC INTERNATIONAL CORP. NO. 200, WEN HUA 2ND RD. GUISHAN DIST. TAOYUAN CITY 33383 TW Other 510(k) Applications for this Company
Contact	YIHAO HUANG Other 510(k) Applications for this Contact
Regulation Number	870.2340   More FDA Info for this Regulation Number
Classification Product Code	DPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2016
Decision Date	01/26/2018
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