Cleared Traditional

BIOEMG III

K082927 · Bio-Research Associates, Inc. · Dental
Feb 2009
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K082927 is an FDA 510(k) clearance for the BIOEMG III, 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 February 6, 2009, 128 days after receiving the submission on October 1, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 890.1375.

Submission Details

510(k) Number K082927 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2008
Decision Date February 06, 2009
Days to Decision 128 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