Cleared Traditional

JEDMED SPECTRUM ENT CABINET

K953457 · Jedmed Instrument Co. · Ear, Nose, Throat
Aug 1995
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K953457 is an FDA 510(k) clearance for the JEDMED SPECTRUM ENT CABINET, 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 August 11, 1995, 21 days after receiving the submission on July 21, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5300.

Submission Details

510(k) Number K953457 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 1995
Decision Date August 11, 1995
Days to Decision 21 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

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