Cleared Traditional

POTTY PAL AND FOREVER-DRY

K971855 · Digital Applications, Inc. · Gastroenterology & Urology
Aug 1997
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K971855 is an FDA 510(k) clearance for the POTTY PAL AND FOREVER-DRY, a Alarm, Conditioned Response Enuresis (Class II — Special Controls, product code KPN), submitted by Digital Applications, Inc. (Santaquin, US). The FDA issued a Cleared decision on August 18, 1997, 90 days after receiving the submission on May 20, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.2040.

Submission Details

510(k) Number K971855 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 1997
Decision Date August 18, 1997
Days to Decision 90 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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