Cleared Traditional

K953434 - MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)
(FDA 510(k) Clearance)

K953434 · Midas Rex Pneumatic Tools, Inc. · Neurology

May 1996

Decision

300d

Days

Class 2

Risk

K953434 is an FDA 510(k) clearance for the MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS), 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 May 16, 1996, 300 days after receiving the submission on July 21, 1995. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4370.

Submission Details

510(k) Number	K953434 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 21, 1995
Decision Date	May 16, 1996
Days to Decision	300 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF