FDA 510(k) Application Details - K183052

Device Classification Name	More FDA Info for this Device
510(K) Number	K183052
Device Name	ID-Cap System
Applicant	etectRx, Inc. 747 SW 2nd Ave Suite 365T, IMB 24 Gainesville, FL 32601 US Other 510(k) Applications for this Company
Contact	Susan Baumgartner Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2018
Decision Date	12/06/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review