Aurora
K-Number: K231355 · 2024-02-09
Device Summary
Frequently Asked Questions
What is the Aurora?
Aurora is a medical device that received FDA 510(k) clearance on 2024-02-09. The listed applicant is Ensodata. The 510(k) number is K231355.
When did Aurora receive FDA 510(k) clearance?
Aurora received FDA 510(k) clearance on 2024-02-09, under 510(k) number K231355.
Who is the listed applicant for Aurora?
The FDA 510(k) record lists Ensodata as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Aurora?
The FDA product code for Aurora is MNR.
Other records listing Ensodata as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: MNR)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.