FDA 510(k) Application Details - K212655

Device Classification Name	Perineometer   More FDA Info for this Device
510(K) Number	K212655
Device Name	Perineometer
Applicant	Pelvital USA, Inc. 1000 LaSalle Avenue, SCH 435 Minneapolis, MN 55403 US Other 510(k) Applications for this Company
Contact	Dale Wahlstrom 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	08/23/2021
Decision Date	09/21/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review