ClearEdge Balance System— 510(k) K183661

Name: FDA 510(k) clearance K183661
Creator: U.S. Food and Drug Administration
Published: 2019-10-22

Substantially Equivalent

Quadrant Biosciences

FDA 510(k) clearance K183661 for ClearEdge Balance System, Substantially Equivalent on 2019-10-22. Applicant: Quadrant Biosciences. Device class: Unclassified.

Clearance details

Applicant: Quadrant Biosciences
Product code: Code LXV
Device class: Unclassified
Advisory panel: Unknown
Date received: 2018-12-27
Decision date: 2019-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Syracuse, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.