Cleared Traditional

NIGHT TRAINER

K834311 · Maddak, Inc. · Gastroenterology & Urology
Mar 1984
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K834311 is an FDA 510(k) clearance for the NIGHT TRAINER, a Alarm, Conditioned Response Enuresis (Class II — Special Controls, product code KPN), submitted by Maddak, Inc. (Walker, US). The FDA issued a Cleared decision on March 30, 1984, 126 days after receiving the submission on November 25, 1983. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.2040.

Submission Details

510(k) Number K834311 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 1983
Decision Date March 30, 1984
Days to Decision 126 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

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

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