Cleared Traditional

BATH TUB TRANSFER CHAIR

K842649 · Guardian Products Co., Inc. · Neurology
Aug 1984
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K842649 is an FDA 510(k) clearance for the BATH TUB TRANSFER CHAIR, a Electromyograph, Diagnostic (Class II — Special Controls, product code IKN), submitted by Guardian Products Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1984, 31 days after receiving the submission on July 10, 1984. This device falls under the Neurology review panel. Regulated under 21 CFR 890.1375.

Submission Details

510(k) Number K842649 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 1984
Decision Date August 10, 1984
Days to Decision 31 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code IKN — Electromyograph, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.1375