PROTURA COUCH SOFTWARE— 510(k) K122201

Name: FDA 510(k) clearance K122201
Creator: U.S. Food and Drug Administration
Published: 2012-08-30

Substantially Equivalent

Med-Tec, Inc. D/B/A Civco Medical Solutions

FDA 510(k) clearance K122201 for PROTURA COUCH SOFTWARE, Substantially Equivalent on 2012-08-30. Applicant: Med-Tec, Inc. D/B/A Civco Medical Solutions. Device class: 2.

Clearance details

Applicant: Med-Tec, Inc. D/B/A Civco Medical Solutions
Product code: Code JAI
Device class: Class 2
Regulation: 21 CFR 892.5770
Advisory panel: Radiology
Date received: 2012-07-25
Decision date: 2012-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange City, IA, US

Download summary PDF View on FDA.gov ↗

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