Cleared Traditional

REMOTE A'LERT

K943559 · Health Sense Intl., Inc. · Gastroenterology & Urology
May 1995
Decision
306d
Days
Class 2
Risk

About This 510(k) Submission

K943559 is an FDA 510(k) clearance for the REMOTE A'LERT, a Alarm, Conditioned Response Enuresis (Class II — Special Controls, product code KPN), submitted by Health Sense Intl., Inc. (Washington, Dc, US). The FDA issued a Cleared decision on May 24, 1995, 306 days after receiving the submission on July 22, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.2040.

Submission Details

510(k) Number K943559 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1994
Decision Date May 24, 1995
Days to Decision 306 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

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