Cleared Traditional

PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)

K123902 · Oktx, LLC · Neurology

Sep 2013

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K123902 is an FDA 510(k) clearance for the PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S), a Electromyograph, Diagnostic (Class II — Special Controls, product code IKN), submitted by Oktx, LLC (Tulsa, US). The FDA issued a Cleared decision on September 13, 2013, 269 days after receiving the submission on December 18, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 890.1375.

Submission Details

510(k) Number	K123902 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 18, 2012
Decision Date	September 13, 2013
Days to Decision	269 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF