FDA 510(k)

ADD (Nombre del Modelo: HAD1417MCW), ADD (Nombre del Modelo: HAD1717MCW)

N.º K: K213497 · 2021-11-15

Fecha de decisión2021-11-15

Código de productoMQB

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) is the device name listed in this FDA 510(k) record. The listed applicant is H&abyz Co., Ltd.. It received FDA 510(k) clearance on 2021-11-15 under 510(k) number K213497. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)?

ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) is a medical device that received FDA 510(k) clearance on 2021-11-15. The listed applicant is H&abyz Co., Ltd.. The 510(k) number is K213497.

When did ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) receive FDA 510(k) clearance?

ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) received FDA 510(k) clearance on 2021-11-15, under 510(k) number K213497.

Who is the listed applicant for ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)?

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

What is the FDA product code for ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)?

The FDA product code for ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) is MQB.

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Otros registros que enlistan a H&abyz Co., Ltd. como solicitante

K251223HnX-P1, HnX-PB K223930A1417MCW/A1717MCW/F1417MCW K203188ADD

Dispositivos relacionados (Código: MQB)

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) Limited K250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

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.