Cleared Traditional

DRYTIME FOR BLADDER CONTROL SILENT

K962416 · Bio-Systems Research · Gastroenterology & Urology
Jul 1996
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K962416 is an FDA 510(k) clearance for the DRYTIME FOR BLADDER CONTROL SILENT, a Alarm, Conditioned Response Enuresis (Class II — Special Controls, product code KPN), submitted by Bio-Systems Research (Lake Oswego, US). The FDA issued a Cleared decision on July 22, 1996, 83 days after receiving the submission on April 30, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.2040.

Submission Details

510(k) Number K962416 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 1996
Decision Date July 22, 1996
Days to Decision 83 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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