FDA 510(k) Application Details - K250940

Device Classification Name	Gastrointestinal Motility System, Capsule   More FDA Info for this Device
510(K) Number	K250940
Device Name	Gastrointestinal Motility System, Capsule
Applicant	Atmo Biosciences Ltd 436 Elgar Rd Box Hill 3128 AU Other 510(k) Applications for this Company
Contact	Ian Macfarlane Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	NYV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2025
Decision Date	06/26/2025
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