FDA 510(k)

Cyware 4H and Cysart 4H

Número K: K221796 · 2022-12-30

Data da decisão2022-12-30

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cyware 4H and Cysart 4H is the device name listed in this FDA 510(k) record. The listed applicant is Abys Medical. It received FDA 510(k) clearance on 2022-12-30 under 510(k) number K221796. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Cyware 4H and Cysart 4H?

Cyware 4H and Cysart 4H is a medical device that received FDA 510(k) clearance on 2022-12-30. The listed applicant is Abys Medical. The 510(k) number is K221796.

When did Cyware 4H and Cysart 4H receive FDA 510(k) clearance?

Cyware 4H and Cysart 4H received FDA 510(k) clearance on 2022-12-30, under 510(k) number K221796.

Who is the listed applicant for Cyware 4H and Cysart 4H?

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

What is the FDA product code for Cyware 4H and Cysart 4H?

The FDA product code for Cyware 4H and Cysart 4H is LLZ.

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