FDA 510(k)

Insufflator

N.º K: K222812 · 2023-05-16

SolicitanteScivita Medical Technology Co., Ltd.

Fecha de decisión2023-05-16

Código de productoHIF

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Insufflator is the device name listed in this FDA 510(k) record. The listed applicant is Scivita Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-05-16 under 510(k) number K222812. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Insufflator?

Insufflator is a medical device that received FDA 510(k) clearance on 2023-05-16. The listed applicant is Scivita Medical Technology Co., Ltd.. The 510(k) number is K222812.

When did Insufflator receive FDA 510(k) clearance?

Insufflator received FDA 510(k) clearance on 2023-05-16, under 510(k) number K222812.

Who is the listed applicant for Insufflator?

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

What is the FDA product code for Insufflator?

The FDA product code for Insufflator is HIF.

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Otros registros que enlistan a Scivita Medical Technology Co., Ltd. como solicitante

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Dispositivos relacionados (Código: HIF)

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Fuente oficial

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