FDA 510(k) Application Details - K971442

Device Classification Name	Alarm, Conditioned Response Enuresis   More FDA Info for this Device
510(K) Number	K971442
Device Name	Alarm, Conditioned Response Enuresis
Applicant	HUMED, INC. 709 N. MEMORIAL PKWY. HUNTSVILLE, AL 35801 US Other 510(k) Applications for this Company
Contact	CHARLES B HUGHES Other 510(k) Applications for this Contact
Regulation Number	876.2040   More FDA Info for this Regulation Number
Classification Product Code	KPN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/21/1997
Decision Date	01/08/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review