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FDA 510(k)

Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo

K-Number: K222395 · 2022-11-02

ApplicantEllex Medical Pty, Ltd.
Decision Date2022-11-02
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo is the device name listed in this FDA 510(k) record. The listed applicant is Ellex Medical Pty, Ltd.. It received FDA 510(k) clearance on 2022-11-02 under 510(k) 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. The listed applicant is Ellex Medical Pty, Ltd.. The 510(k) number is K222395.

When did Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo receive FDA 510(k) clearance?

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

Who is the listed applicant for Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo?

The FDA 510(k) record lists Ellex Medical Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Ellex Medical Pty, Ltd. 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.

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Related Devices (Code: HQF)

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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.

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