Aurora— 510(k) K231355

Substantially Equivalent

Ensodata

FDA 510(k) clearance K231355 for Aurora, Substantially Equivalent on 2024-02-09. Applicant: Ensodata.

Clearance details

Applicant: Ensodata
Product code: Code MNR
Advisory panel: Anesthesiology
Date received: 2023-05-10
Decision date: 2024-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

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