MODEL GST-1— 510(k) K040193

Name: FDA 510(k) clearance K040193
Creator: U.S. Food and Drug Administration
Published: 2004-04-27

Substantially Equivalent

Medical Equipment Device Specialists

FDA 510(k) clearance K040193 for MODEL GST-1, Substantially Equivalent on 2004-04-27. Applicant: Medical Equipment Device Specialists. Device class: 2.

Clearance details

Applicant: Medical Equipment Device Specialists
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2004-01-28
Decision date: 2004-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, US

Download summary PDF View on FDA.gov ↗

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