FDA 510(k)

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

K号: K212630 · 2021-12-16

决定日期2021-12-16

产品代码HQF

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决定实质等同

器械摘要

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.

常见问题

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.

列明Ellex Medical Pty, Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K222395Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo K190786Eye Prime

官方来源

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