THE ROBOGUIDE— 510(k) K961849

Name: FDA 510(k) clearance K961849
Creator: U.S. Food and Drug Administration
Published: 1996-08-21

Substantially Equivalent

Shai Syg Motion and Innovations, Ltd.

FDA 510(k) clearance K961849 for THE ROBOGUIDE, Substantially Equivalent on 1996-08-21. Applicant: Shai Syg Motion and Innovations, Ltd.. Device class: 2.

Clearance details

Applicant: Shai Syg Motion and Innovations, Ltd.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1996-05-13
Decision date: 1996-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Efrat, IL

Download summary PDF View on FDA.gov ↗

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