FDA 510(k) Application Details - K190208

Device Classification Name	System, Gastrointestinal Motility (Electrical)   More FDA Info for this Device
510(K) Number	K190208
Device Name	System, Gastrointestinal Motility (Electrical)
Applicant	Diversatek Healthcare 9150 Commerce Center Circle Suite 500 Highlands Ranch, CO 80129 US Other 510(k) Applications for this Company
Contact	Laura L. Boll Other 510(k) Applications for this Contact
Regulation Number	876.1725   More FDA Info for this Regulation Number
Classification Product Code	FFX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/2019
Decision Date	10/03/2019
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