FDA 510(k) Application Details - K240847

Device Classification Name	Insufflator, Automatic Carbon-Dioxide For Endoscope   More FDA Info for this Device
510(K) Number	K240847
Device Name	Insufflator, Automatic Carbon-Dioxide For Endoscope
Applicant	IDE Vision Ltd Lodge Way Portskewett Caldicot NP265PS GB Other 510(k) Applications for this Company
Contact	Nicholas See 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	03/27/2024
Decision Date	10/30/2024
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