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FDA 510(k)

Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo

K-Number: K212630 · 2021-12-16

ApplicantEllex Medical Pty, Ltd.
Decision Date2021-12-16
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo 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 2021-12-16 under 510(k) number K212630. 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, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo?

Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is Ellex Medical Pty, Ltd.. The 510(k) number is K212630.

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

Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo received FDA 510(k) clearance on 2021-12-16, under 510(k) number K212630.

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

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, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo?

The FDA product code for Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo 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.

K222395Tango Neo, Tango Reflex Neo, Ultra Q Reflex NeoK190786Eye Prime

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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.

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