FDA 510(k) Application Details - K172778

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K172778
Device Name	Electrocardiograph
Applicant	DailyCare Biomedical, Inc 7f, No. 1, Ding-An Rd, Zhongli Dist. Taoyuan City Taoyuan 320 TW Other 510(k) Applications for this Company
Contact	Ming Da Lee 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	09/14/2017
Decision Date	07/05/2018
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