Cleared Traditional

EVT-3300

K953621 · U.S. Table, Inc. · Physical Medicine
Nov 1995
Decision
103d
Days
Class 1
Risk

About This 510(k) Submission

K953621 is an FDA 510(k) clearance for the EVT-3300, a Table, Powered (Class I — General Controls, product code INQ), submitted by U.S. Table, Inc. (Glen Allen, US). The FDA issued a Cleared decision on November 14, 1995, 103 days after receiving the submission on August 3, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3760.

Submission Details

510(k) Number K953621 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 1995
Decision Date November 14, 1995
Days to Decision 103 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code INQ — Table, Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3760

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