FDA 510(k) Application Details - K222932

Device Classification Name	More FDA Info for this Device
510(K) Number	K222932
Device Name	INVOcell Intravaginal Culture System
Applicant	INVO Bioscience 5582 Broadcast Court Sarasota, FL 34240 US Other 510(k) Applications for this Company
Contact	Steve Shum Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2022
Decision Date	06/22/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review