FDA 510(k) Application Details - K983052

Device Classification Name	Perineometer   More FDA Info for this Device
510(K) Number	K983052
Device Name	Perineometer
Applicant	CARDIO DESIGN PTY. LTD. P.O. BOX 6407 BHBC BAULKHAM HILLS NSW 2153 AU Other 510(k) Applications for this Company
Contact	NEVILLE MOTLEY 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	09/01/1998
Decision Date	10/19/1998
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