FDA 510(k)

Tristel OPH

Número K: K242732 · 2025-05-09

Data da decisão2025-05-09

Código do produtoQWS

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Tristel OPH is the device name listed in this FDA 510(k) record. The listed applicant is Tristel Solutions , Ltd.. It received FDA 510(k) clearance on 2025-05-09 under 510(k) number K242732. The device is classified under product code QWS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Tristel OPH?

Tristel OPH is a medical device that received FDA 510(k) clearance on 2025-05-09. The listed applicant is Tristel Solutions , Ltd.. The 510(k) number is K242732.

When did Tristel OPH receive FDA 510(k) clearance?

Tristel OPH received FDA 510(k) clearance on 2025-05-09, under 510(k) number K242732.

Who is the listed applicant for Tristel OPH?

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

What is the FDA product code for Tristel OPH?

The FDA product code for Tristel OPH is QWS.

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