Cleared Traditional

BIOPAK MEASUREMENT SYSTEM

K981563 · Bio-Research Associates, Inc. · Dental
Sep 1998
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K981563 is an FDA 510(k) clearance for the BIOPAK MEASUREMENT SYSTEM, 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 September 15, 1998, 137 days after receiving the submission on May 1, 1998. This device falls under the Dental review panel. Regulated under 21 CFR 890.1375.

Submission Details

510(k) Number K981563 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1998
Decision Date September 15, 1998
Days to Decision 137 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