Cleared Special

MODEL K7 EVALUATION DEVICE

K003287 · Myotronics-Noromed, Inc. · Dental
Nov 2000
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K003287 is an FDA 510(k) clearance for the MODEL K7 EVALUATION DEVICE, a Device, Muscle Monitoring (Class II — Special Controls, product code KZM), submitted by Myotronics-Noromed, Inc. (Tukwila, US). The FDA issued a Cleared decision on November 6, 2000, 17 days after receiving the submission on October 20, 2000. This device falls under the Dental review panel. Regulated under 21 CFR 890.1375.

Submission Details

510(k) Number K003287 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 2000
Decision Date November 06, 2000
Days to Decision 17 days
Submission Type Special
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