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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
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