Cleared Traditional

K962483 - MIDAS REX III MOTOR
(FDA 510(k) Clearance)

K962483 · Midas Rex Pneumatic Tools, Inc. · Neurology
Nov 1996
Decision
146d
Days
Class 2
Risk

K962483 is an FDA 510(k) clearance for the MIDAS REX III MOTOR, a Motor, Drill, Pneumatic (Class II — Special Controls, product code HBB), submitted by Midas Rex Pneumatic Tools, Inc. (Fort Worth, US). The FDA issued a Cleared decision on November 19, 1996, 146 days after receiving the submission on June 26, 1996. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4370.

Submission Details

510(k) Number K962483 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 1996
Decision Date November 19, 1996
Days to Decision 146 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBB — Motor, Drill, Pneumatic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4370

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