Cleared Special

MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I

K992694 · Myotronics-Noromed, Inc. · Dental
Sep 1999
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K992694 is an FDA 510(k) clearance for the MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I, 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 September 10, 1999, 29 days after receiving the submission on August 12, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 890.1375.

Submission Details

510(k) Number K992694 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1999
Decision Date September 10, 1999
Days to Decision 29 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