FDA 510(k)

BcSs-PICNI-2000 Sensor

N.º K: K182073 · 2019-10-17

SolicitanteBraincare Desenvolvimento E Inovacao Tecnologica S.A.

Fecha de decisión2019-10-17

Código de productoGWM

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

BcSs-PICNI-2000 Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Braincare Desenvolvimento E Inovacao Tecnologica S.A.. It received FDA 510(k) clearance on 2019-10-17 under 510(k) number K182073. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BcSs-PICNI-2000 Sensor?

BcSs-PICNI-2000 Sensor is a medical device that received FDA 510(k) clearance on 2019-10-17. The listed applicant is Braincare Desenvolvimento E Inovacao Tecnologica S.A.. The 510(k) number is K182073.

When did BcSs-PICNI-2000 Sensor receive FDA 510(k) clearance?

BcSs-PICNI-2000 Sensor received FDA 510(k) clearance on 2019-10-17, under 510(k) number K182073.

Who is the listed applicant for BcSs-PICNI-2000 Sensor?

The FDA 510(k) record lists Braincare Desenvolvimento E Inovacao Tecnologica S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BcSs-PICNI-2000 Sensor?

The FDA product code for BcSs-PICNI-2000 Sensor is GWM.

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Otros registros que enlistan a Braincare Desenvolvimento E Inovacao Tecnologica S.A. como solicitante

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Dispositivos relacionados (Código: GWM)

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