FDA 510(k)

STS

Número K: K240293 · 2024-09-17

Data da decisão2024-09-17

Código do produtoBZC

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

STS is the device name listed in this FDA 510(k) record. The listed applicant is Techbopulm, Ltd.. It received FDA 510(k) clearance on 2024-09-17 under 510(k) number K240293. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the STS?

STS is a medical device that received FDA 510(k) clearance on 2024-09-17. The listed applicant is Techbopulm, Ltd.. The 510(k) number is K240293.

When did STS receive FDA 510(k) clearance?

STS received FDA 510(k) clearance on 2024-09-17, under 510(k) number K240293.

Who is the listed applicant for STS?

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

What is the FDA product code for STS?

The FDA product code for STS is BZC.

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