FDA 510(k) Application Details - K230056

Device Classification Name	More FDA Info for this Device
510(K) Number	K230056
Device Name	MiVuÖ Esophageal Endo Cap
Applicant	Diversatek Healthcare 9150 Commerce Center Circle, Suite 500 Highlands Ranch, CO 80129 US Other 510(k) Applications for this Company
Contact	Jim Prinster 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	01/09/2023
Decision Date	04/25/2023
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