FDA 510(k)

Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo

K-Number: K222395 · 2022-11-02

Decision Date2022-11-02

Product CodeHQF

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo is a medical device manufactured by Ellex Medical Pty, Ltd.. It received FDA 510(k) clearance on 2022-11-02 under approval number K222395. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo?

Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo is a medical device that received FDA 510(k) clearance on 2022-11-02. It is manufactured by Ellex Medical Pty, Ltd.. The 510(k) number is K222395.

When was Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo approved by the FDA?

Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo received FDA 510(k) clearance on 2022-11-02, under approval number K222395.

What company makes Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo?

Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo is manufactured by Ellex Medical Pty, Ltd..

What is the FDA product code for Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo?

The FDA product code for Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo is HQF.

Other Devices by Ellex Medical Pty, Ltd.

K190786Eye Prime K212630Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo

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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.