FDA 510(k) Application Details - K230474

Device Classification Name	Insufflator, Automatic Carbon-Dioxide For Endoscope   More FDA Info for this Device
510(K) Number	K230474
Device Name	Insufflator, Automatic Carbon-Dioxide For Endoscope
Applicant	Palliare Ltd. Galway Business Park, Dangan Galway H91 P2DK IE Other 510(k) Applications for this Company
Contact	John O'Dea Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/22/2023
Decision Date	03/24/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review