FDA 510(k) Application Details - K213686

Device Classification Name	More FDA Info for this Device
510(K) Number	K213686
Device Name	SKOUT Software
Applicant	Iterative Scopes Inc. 14 Arrow St, 3rd Floor Cambridge, MA 02138 US Other 510(k) Applications for this Company
Contact	Daniel Wang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2021
Decision Date	08/12/2022
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