MONITORING DEVICE ENURESIS ALARM & ACC.— 510(k) K821546

Name: FDA 510(k) clearance K821546
Creator: U.S. Food and Drug Administration
Published: 1982-06-09

Substantially Equivalent

Wetbell, Inc.

FDA 510(k) clearance K821546 for MONITORING DEVICE ENURESIS ALARM & ACC., Substantially Equivalent on 1982-06-09. Applicant: Wetbell, Inc.. Device class: 2.

Clearance details

Applicant: Wetbell, Inc.
Product code: Code KPN
Device class: Class 2
Regulation: 21 CFR 876.2040
Advisory panel: Gastroenterology, Urology
Date received: 1982-05-25
Decision date: 1982-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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