FDA 510(k)

Anura Mobile Core SDK (M1)

Номер K: K253650 · 2026-06-11

Дата решения2026-06-11

Код продуктаQME

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

Anura Mobile Core SDK (M1) is the device name listed in this FDA 510(k) record. The listed applicant is Nuralogix Corporation. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K253650. The device is classified under product code QME. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Anura Mobile Core SDK (M1)?

Anura Mobile Core SDK (M1) is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Nuralogix Corporation. The 510(k) number is K253650.

When did Anura Mobile Core SDK (M1) receive FDA 510(k) clearance?

Anura Mobile Core SDK (M1) received FDA 510(k) clearance on 2026-06-11, under 510(k) number K253650.

Who is the listed applicant for Anura Mobile Core SDK (M1)?

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

What is the FDA product code for Anura Mobile Core SDK (M1)?

The FDA product code for Anura Mobile Core SDK (M1) is QME.

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: QME)

K254169SmartSpectra Vital Signs Monitor 1.0Presage Security, Inc. d/b/a Presage Technologies, Inc.K260066PanopticAI Vital Signs (1.6.1-22)PanopticAI Technologies Limited K251200Vital SignsOxehealth Limited K243687Vital SignsOxehealth Limited K250078Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)Mindset Medical, Inc.K240890PanopticAI Vital SignsPanopticAI technologies Limited

Официальный источник

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