FDA 510(k)

SONON Ultrasound Imaging System, Model: SONON300C

N.º K: K211665 · 2022-05-16

Fecha de decisión2022-05-16

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

SONON Ultrasound Imaging System, Model: SONON300C is the device name listed in this FDA 510(k) record. The listed applicant is Healcerion Co., Ltd.. It received FDA 510(k) clearance on 2022-05-16 under 510(k) number K211665. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SONON Ultrasound Imaging System, Model: SONON300C?

SONON Ultrasound Imaging System, Model: SONON300C is a medical device that received FDA 510(k) clearance on 2022-05-16. The listed applicant is Healcerion Co., Ltd.. The 510(k) number is K211665.

When did SONON Ultrasound Imaging System, Model: SONON300C receive FDA 510(k) clearance?

SONON Ultrasound Imaging System, Model: SONON300C received FDA 510(k) clearance on 2022-05-16, under 510(k) number K211665.

Who is the listed applicant for SONON Ultrasound Imaging System, Model: SONON300C?

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

What is the FDA product code for SONON Ultrasound Imaging System, Model: SONON300C?

The FDA product code for SONON Ultrasound Imaging System, Model: SONON300C is IYN.

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Otros registros que enlistan a Healcerion Co., Ltd. como solicitante

K212400SONON Ultrasound Imaging System, Model: SONON 500L K170085SONON Ultrasound Imaging System, Model: 300L

Dispositivos relacionados (Código: IYN)

Fuente oficial

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