Cleared Traditional

M-SCAN

K130158 · Bio-Research Associates, Inc. · Dental
Jul 2013
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K130158 is an FDA 510(k) clearance for the M-SCAN, a Device, Muscle Monitoring (Class II — Special Controls, product code KZM), submitted by Bio-Research Associates, Inc. (Brown Deer, US). The FDA issued a Cleared decision on July 25, 2013, 183 days after receiving the submission on January 23, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 890.1375.

Submission Details

510(k) Number K130158 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2013
Decision Date July 25, 2013
Days to Decision 183 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KZM — Device, Muscle Monitoring
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.1375