FDA 510(k)

Tesera-k PL System and Tesera-k XL System

Número K: K242771 · 2025-03-20

RequerenteKyocera Medical Technologies, Inc.

Data da decisão2025-03-20

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Tesera-k PL System and Tesera-k XL System is the device name listed in this FDA 510(k) record. The listed applicant is Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2025-03-20 under 510(k) number K242771. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Tesera-k PL System and Tesera-k XL System?

Tesera-k PL System and Tesera-k XL System is a medical device that received FDA 510(k) clearance on 2025-03-20. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K242771.

When did Tesera-k PL System and Tesera-k XL System receive FDA 510(k) clearance?

Tesera-k PL System and Tesera-k XL System received FDA 510(k) clearance on 2025-03-20, under 510(k) number K242771.

Who is the listed applicant for Tesera-k PL System and Tesera-k XL System?

The FDA 510(k) record lists Kyocera Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tesera-k PL System and Tesera-k XL System?

The FDA product code for Tesera-k PL System and Tesera-k XL System is MAX.

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Fonte oficial

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