K6-1 DIAGNOSTIC SYSTEM VERSION 3.1— 510(k) K944134

Name: FDA 510(k) clearance K944134
Creator: U.S. Food and Drug Administration
Published: 1994-12-09

Substantially Equivalent

Myo-Tronics, Inc.

FDA 510(k) clearance K944134 for K6-1 DIAGNOSTIC SYSTEM VERSION 3.1, Substantially Equivalent on 1994-12-09. Applicant: Myo-Tronics, Inc.. Device class: 2.

Clearance details

Applicant: Myo-Tronics, Inc.
Product code: Code KZM
Device class: Class 2
Regulation: 21 CFR 890.1375
Advisory panel: Physical Medicine
Date received: 1994-08-24
Decision date: 1994-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tukwila, WA, US

Download summary PDF View on FDA.gov ↗

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