Rubicon SA System— 510(k) K200654

Substantially Equivalent

Dymedix Diagnostics, Inc.

FDA 510(k) clearance K200654 for Rubicon SA System, Substantially Equivalent on 2020-07-22. Applicant: Dymedix Diagnostics, Inc..

Clearance details

Applicant: Dymedix Diagnostics, Inc.
Product code: Code MNR
Advisory panel: Anesthesiology
Date received: 2020-03-12
Decision date: 2020-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shoreview, MN, US

Download summary PDF View on FDA.gov ↗

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