PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100— 510(k) K034054

Name: FDA 510(k) clearance K034054
Creator: U.S. Food and Drug Administration
Published: 2004-02-20

Substantially Equivalent

Med-Tec,Inc.

FDA 510(k) clearance K034054 for PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100, Substantially Equivalent on 2004-02-20. Applicant: Med-Tec,Inc.. Device class: 2.

Clearance details

Applicant: Med-Tec,Inc.
Product code: Code JAI
Device class: Class 2
Regulation: 21 CFR 892.5770
Advisory panel: Radiology
Date received: 2003-12-30
Decision date: 2004-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange City, IA, US

Download summary PDF View on FDA.gov ↗

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