Cleared Traditional

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
Jan 1998
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K971442 is an FDA 510(k) clearance for the 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, a Alarm, Conditioned Response Enuresis (Class II — Special Controls, product code KPN), submitted by Humed, Inc. (Huntsville, US). The FDA issued a Cleared decision on January 8, 1998, 262 days after receiving the submission on April 21, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.2040.

Submission Details

510(k) Number K971442 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 1997
Decision Date January 08, 1998
Days to Decision 262 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KPN — Alarm, Conditioned Response Enuresis
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.2040