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FDA 510(k) Application Details - DEN220065
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN220065
Device Name
Pill Sense System
Applicant
EnteraSense Ltd.
Unit 3 Ballybrit Business Park, Mervue
Galway H91 DT7C IE
Other 510(k) Applications for this Company
Contact
David Collins
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QUD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2022
Decision Date
02/24/2023
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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