FDA 510(k) Application Details - K182196

Device Classification Name	Stethoscope, Electronic   More FDA Info for this Device
510(K) Number	K182196
Device Name	Stethoscope, Electronic
Applicant	Imediplus, Inc. 2F, 12, ShengYi Rd. Sec.2 Chupei City 30261 TW Other 510(k) Applications for this Company
Contact	Moriah Hsieh Other 510(k) Applications for this Contact
Regulation Number	870.1875   More FDA Info for this Regulation Number
Classification Product Code	DQD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/14/2018
Decision Date	09/11/2018
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	Y
Expedited Review