FDA 510(k) Application Details - DEN180067

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN180067
Device Name	Mucosal Integrity Conductivity (MI) Test System
Applicant	Diversatek Healthcare Inc. 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	More FDA Info for this Regulation Number
Classification Product Code	QIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2018
Decision Date	12/23/2019
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review