FDA 510(k) Application Details - K222000

Device Classification Name	System, Gastrointestinal Motility (Electrical)   More FDA Info for this Device
510(K) Number	K222000
Device Name	System, Gastrointestinal Motility (Electrical)
Applicant	Medifactia AB C/O IOffice Buisness Center Kungsgatan 60 Stockholm 11122 SE Other 510(k) Applications for this Company
Contact	Diana Nystrom Other 510(k) Applications for this Contact
Regulation Number	876.1725   More FDA Info for this Regulation Number
Classification Product Code	FFX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/07/2022
Decision Date	01/18/2023
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