FDA 510(k) Application Details - K183585

Device Classification Name	More FDA Info for this Device
510(K) Number	K183585
Device Name	Elitone Device
Applicant	Elidah, Inc. 810 Main St., Ste C Monroe, CT 06468 US Other 510(k) Applications for this Company
Contact	Gloria Kolb Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2018
Decision Date	02/11/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review