FDA 510(k) Application Details - K970145

Device Classification Name	Perineometer   More FDA Info for this Device
510(K) Number	K970145
Device Name	Perineometer
Applicant	BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 SOMERVILLE, NJ 08876 US Other 510(k) Applications for this Company
Contact	MARTIN DYCK 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	01/15/1997
Decision Date	08/11/1997
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