THE ARTAS SYSTEM FROM RESTORATION ROBOTICS— 510(k) K103428

Name: FDA 510(k) clearance K103428
Creator: U.S. Food and Drug Administration
Published: 2011-04-04

Substantially Equivalent

Restoration Robotics, Inc.

FDA 510(k) clearance K103428 for THE ARTAS SYSTEM FROM RESTORATION ROBOTICS, Substantially Equivalent on 2011-04-04. Applicant: Restoration Robotics, Inc.. Device class: 2.

Clearance details

Applicant: Restoration Robotics, Inc.
Product code: Code ONA
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2010-11-22
Decision date: 2011-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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