FDA 510(k)

EXTRON 3; EXTRON 5; EXTRON 7

N.º K: K250010 · 2025-06-10

Fecha de decisión2025-06-10

Código de productoOWB

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

EXTRON 3; EXTRON 5; EXTRON 7 is the device name listed in this FDA 510(k) record. The listed applicant is DRTECH Corporation. It received FDA 510(k) clearance on 2025-06-10 under 510(k) number K250010. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the EXTRON 3; EXTRON 5; EXTRON 7?

EXTRON 3; EXTRON 5; EXTRON 7 is a medical device that received FDA 510(k) clearance on 2025-06-10. The listed applicant is DRTECH Corporation. The 510(k) number is K250010.

When did EXTRON 3; EXTRON 5; EXTRON 7 receive FDA 510(k) clearance?

EXTRON 3; EXTRON 5; EXTRON 7 received FDA 510(k) clearance on 2025-06-10, under 510(k) number K250010.

Who is the listed applicant for EXTRON 3; EXTRON 5; EXTRON 7?

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

What is the FDA product code for EXTRON 3; EXTRON 5; EXTRON 7?

The FDA product code for EXTRON 3; EXTRON 5; EXTRON 7 is OWB.

Ensayos clínicos relacionados

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Otros registros que enlistan a DRTECH Corporation como solicitante

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Dispositivos relacionados (Código: OWB)

K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.K261413EXTRON 3;EXTRON 6DRTECH Corporation K254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.

Fuente oficial

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