FDA 510(k)

Aurora

K-Number: K181636 · 2018-07-20

Decision Date2018-07-20

Product CodeMUH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Aurora is the device name listed in this FDA 510(k) record. The listed applicant is Sodium Systems, LLC. It received FDA 510(k) clearance on 2018-07-20 under 510(k) number K181636. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aurora?

Aurora is a medical device that received FDA 510(k) clearance on 2018-07-20. The listed applicant is Sodium Systems, LLC. The 510(k) number is K181636.

When did Aurora receive FDA 510(k) clearance?

Aurora received FDA 510(k) clearance on 2018-07-20, under 510(k) number K181636.

Who is the listed applicant for Aurora?

The FDA 510(k) record lists Sodium Systems, LLC 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 MUH.

Related Devices (Code: MUH)

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K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.