FDA 510(k)

Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)

Номер K: K222364 · 2022-11-16

Дата решения2022-11-16

Код продуктаOAP

Консультативный комитетPM

РешениеSubstantially Equivalent

Описание устройства

Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA) is the device name listed in this FDA 510(k) record. The listed applicant is Xtrallux, LLC. It received FDA 510(k) clearance on 2022-11-16 under 510(k) number K222364. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)?

Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA) is a medical device that received FDA 510(k) clearance on 2022-11-16. The listed applicant is Xtrallux, LLC. The 510(k) number is K222364.

When did Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA) receive FDA 510(k) clearance?

Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA) received FDA 510(k) clearance on 2022-11-16, under 510(k) number K222364.

Who is the listed applicant for Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)?

The FDA 510(k) record lists Xtrallux, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)?

The FDA product code for Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA) is OAP.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: OAP)

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Официальный источник

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