Cleared Traditional

COMMODE CHAIR 98200

K842651 · Guardian Products Co., Inc. · Physical Medicine
Aug 1984
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K842651 is an FDA 510(k) clearance for the COMMODE CHAIR 98200, a Adaptor, Hygiene (Class I — General Controls, product code ILS), submitted by Guardian Products Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 7, 1984, 28 days after receiving the submission on July 10, 1984. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5050.

Submission Details

510(k) Number K842651 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 1984
Decision Date August 07, 1984
Days to Decision 28 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ILS — Adaptor, Hygiene
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5050