FDA 510(k) Application Details - K993411

Device Classification Name	Perineometer   More FDA Info for this Device
510(K) Number	K993411
Device Name	Perineometer
Applicant	MEGA ELECTRONICS LTD. 200 NORTH MAIN ST. SOUTH BUILDING, SUITE 6 EAST LONGMEADOW, MA 01028 US Other 510(k) Applications for this Company
Contact	DAVID MAHONEY 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	10/12/1999
Decision Date	01/10/2000
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