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FDA 510(k)

Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869

N.º K: K213545 · 2023-02-02

SolicitanteSteelco S.P.A.
Fecha de decisión2023-02-02
Código de productoFLE
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 is the device name listed in this FDA 510(k) record. The listed applicant is Steelco S.P.A.. It received FDA 510(k) clearance on 2023-02-02 under 510(k) number K213545. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869?

Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 is a medical device that received FDA 510(k) clearance on 2023-02-02. The listed applicant is Steelco S.P.A.. The 510(k) number is K213545.

When did Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 receive FDA 510(k) clearance?

Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 received FDA 510(k) clearance on 2023-02-02, under 510(k) number K213545.

Who is the listed applicant for Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869?

The FDA 510(k) record lists Steelco S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869?

The FDA product code for Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 is FLE.

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Dispositivos relacionados (Código: FLE)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K261055AMSCO 700 Steam SterilizerSTERIS CorporationK260254Enbio PROEnbio Group AGK252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company)K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas LifecareK250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.K243994Steam Sterilizer (2545D)Ningbo Ican Machines Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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