Cleared Traditional

MOBILE TREATMENT CART

K910243 · Jedmed Instrument Co. · Ear, Nose, Throat
Apr 1991
Decision
85d
Days
Class 1
Risk

About This 510(k) Submission

K910243 is an FDA 510(k) clearance for the MOBILE TREATMENT CART, a Unit, Examining/treatment, Ent (Class I — General Controls, product code ETF), submitted by Jedmed Instrument Co. (St.Louis, US). The FDA issued a Cleared decision on April 17, 1991, 85 days after receiving the submission on January 22, 1991. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5300.

Submission Details

510(k) Number K910243 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 1991
Decision Date April 17, 1991
Days to Decision 85 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code ETF — Unit, Examining/treatment, Ent
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.5300

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