FDA 510(k)

VELO Respiratory Test

K-Number: K251742 · 2026-02-13

Decision Date2026-02-13

Product CodeQOF

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the VELO Respiratory Test?

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

When was VELO Respiratory Test approved by the FDA?

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

What company makes VELO Respiratory Test?

VELO Respiratory Test is manufactured by Lex Diagnostics Limited.

What is the FDA product code for VELO Respiratory Test?

The FDA product code for VELO Respiratory Test is QOF.

Related Devices (Code: QOF)

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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.