FDA 510(k) Application Details - K974036

Device Classification Name	Perineometer   More FDA Info for this Device
510(K) Number	K974036
Device Name	Perineometer
Applicant	THE PROMETHEUS GROUP 2 MALLARDS COVE DUXBURY, MA 02332 US Other 510(k) Applications for this Company
Contact	RICHARD HORTON 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	10/24/1997
Decision Date	12/22/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review