MODEL MES-9000/EMG SYSTEM— 510(k) K013399

Name: FDA 510(k) clearance K013399
Creator: U.S. Food and Drug Administration
Published: 2001-11-13

Substantially Equivalent

Myotronics-Noromed, Inc.

FDA 510(k) clearance K013399 for MODEL MES-9000/EMG SYSTEM, Substantially Equivalent on 2001-11-13. Applicant: Myotronics-Noromed, Inc.. Device class: 2.

Clearance details

Applicant: Myotronics-Noromed, Inc.
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 2001-10-15
Decision date: 2001-11-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Tukwila, WA, US

Download summary PDF View on FDA.gov ↗

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