FDA 510(k) Application Details - DEN210032

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN210032
Device Name	AccuMeasure System
Applicant	RQMIS Inc. 110 Haverhill Road Suite 524 Amesbury, MA 01913 US Other 510(k) Applications for this Company
Contact	Barry Sands Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QTH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2021
Decision Date	07/26/2022
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