Cleared Traditional

DRY TIME

K911279 · Health Sense Intl., Inc. · Gastroenterology & Urology
Sep 1991
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K911279 is an FDA 510(k) clearance for the DRY TIME, a Alarm, Conditioned Response Enuresis (Class II — Special Controls, product code KPN), submitted by Health Sense Intl., Inc. (Coos Bay, US). The FDA issued a Cleared decision on September 4, 1991, 163 days after receiving the submission on March 25, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.2040.

Submission Details

510(k) Number K911279 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 1991
Decision Date September 04, 1991
Days to Decision 163 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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