FDA 510(k) Application Details - K160758

Device Classification Name	Perineometer   More FDA Info for this Device
510(K) Number	K160758
Device Name	Perineometer
Applicant	ANALYTICA LTD. 320 ADELAIDE STREET BRISBANE 4000 AU Other 510(k) Applications for this Company
Contact	GEOFF DALY 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	03/18/2016
Decision Date	07/11/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review