KPN · Class II · 21 CFR 876.2040

FDA Product Code KPN: Alarm, Conditioned Response Enuresis

Leading manufacturers include Simavita Pty Limited, Maddak, Inc. and C.R. Bard, Inc..

37
Total
37
Cleared
112d
Avg days
1978
Since

FDA 510(k) Cleared Alarm, Conditioned Response Enuresis Devices (Product Code KPN)

37 devices
1–24 of 37
Cleared Aug 22, 2013
SIM
K130951
Simavita Pty Limited
Gastroenterology & Urology · 139d
Cleared Jan 08, 1998
HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED-T-10,MED-T-25,MED-T-5
K971442
Humed, Inc.
Gastroenterology & Urology · 262d
Cleared Aug 18, 1997
POTTY PAL AND FOREVER-DRY
K971855
Digital Applications, Inc.
Gastroenterology & Urology · 90d
Cleared Aug 01, 1996
UROSURGE ACUTRAINER
K962770
Princeton Regulatory Assoc.
Gastroenterology & Urology · 16d
Cleared Jul 22, 1996
DRYTIME FOR BLADDER CONTROL SILENT
K962416
Bio-Systems Research
Gastroenterology & Urology · 83d
Cleared Mar 12, 1996
DRYTIME FOR POTTY TRAINING
K955338
Health Sense Intl., Inc.
Gastroenterology & Urology · 112d
Cleared Nov 13, 1989
BARD INTRAVAGINAL STIM. KIT W/(IVES(TM))
K895251
C.R. Bard, Inc.
Gastroenterology & Urology · 84d
Cleared Mar 30, 1984
NIGHT TRAINER
K834311
Maddak, Inc.
Gastroenterology & Urology · 126d

About Product Code KPN - Regulatory Context