FDA 510(k)

VELO Respiratory Test

K番号: K251742 · 2026-02-13

決定日2026-02-13

製品コードQOF

諮問委員会MI

決定Substantially Equivalent

医療機器の概要

VELO Respiratory Test is the device name listed in this FDA 510(k) record. The listed applicant is Lex Diagnostics Limited. It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K251742. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the VELO Respiratory Test?

VELO Respiratory Test is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is Lex Diagnostics Limited. The 510(k) number is K251742.

When did VELO Respiratory Test receive FDA 510(k) clearance?

VELO Respiratory Test received FDA 510(k) clearance on 2026-02-13, under 510(k) number K251742.

Who is the listed applicant for VELO Respiratory Test?

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

What is the FDA product code for VELO Respiratory Test?

The FDA product code for VELO Respiratory Test is QOF.

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VELO Respiratory Test

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：QOF）

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