FDA 510(k) Application Details - K231875

Device Classification Name	Perineometer   More FDA Info for this Device
510(K) Number	K231875
Device Name	Perineometer
Applicant	Advanced Tactile Imaging Inc. 1457 Lower Ferry Rd Ewing, NJ 08618 US Other 510(k) Applications for this Company
Contact	Brendan Francy Other 510(k) Applications for this Contact
Regulation Number	884.1425   More FDA Info for this Regulation Number
Classification Product Code	HIR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/26/2023
Decision Date	02/22/2024
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