SATURNE MULTILEAF COLLIMATOR— 510(k) K970303

Name: FDA 510(k) clearance K970303
Creator: U.S. Food and Drug Administration
Published: 1997-04-25

Substantially Equivalent

General Electric Co.

FDA 510(k) clearance K970303 for SATURNE MULTILEAF COLLIMATOR, Substantially Equivalent on 1997-04-25. Applicant: General Electric Co.. Device class: 2.

Clearance details

Applicant: General Electric Co.
Product code: Code IXI
Device class: Class 2
Regulation: 21 CFR 892.5710
Advisory panel: Radiology
Date received: 1997-01-27
Decision date: 1997-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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