Cleared Traditional

K972289 - MIDAS REX MOTOR
(FDA 510(k) Clearance)

K972289 · Midas Rex Pneumatic Tools, Inc. · Neurology

Sep 1997

Decision

85d

Days

Class 2

Risk

K972289 is an FDA 510(k) clearance for the MIDAS REX 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 September 12, 1997, 85 days after receiving the submission on June 19, 1997. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4370.

Submission Details

510(k) Number	K972289 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 19, 1997
Decision Date	September 12, 1997
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF