FDA 510(k)

Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)

N.º K: K251268 · 2025-12-23

Fecha de decisión2025-12-23

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K251268. 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 Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)?

Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K251268.

When did Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) receive FDA 510(k) clearance?

Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) received FDA 510(k) clearance on 2025-12-23, under 510(k) number K251268.

Who is the listed applicant for Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)?

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

What is the FDA product code for Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)?

The FDA product code for Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) is IYN.

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Otros registros que enlistan a Edan Instruments, Inc. como solicitante

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Dispositivos relacionados (Código: IYN)

Fuente oficial

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