Cleared Traditional

BIOEMG II AND BIOJVA

K003176 · Bio-Research Associates, Inc. · Dental
Jan 2001
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K003176 is an FDA 510(k) clearance for the BIOEMG II AND BIOJVA, a Device, Muscle Monitoring (Class II — Special Controls, product code KZM), submitted by Bio-Research Associates, Inc. (Milwaukee, US). The FDA issued a Cleared decision on January 4, 2001, 85 days after receiving the submission on October 11, 2000. This device falls under the Dental review panel. Regulated under 21 CFR 890.1375.

Submission Details

510(k) Number K003176 FDA.gov
FDA Decision Cleared SESE
Date Received October 11, 2000
Decision Date January 04, 2001
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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