FDA 510(k)

Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers

N.º K: K160442 · 2016-10-21

Fecha de decisión2016-10-21

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers is the device name listed in this FDA 510(k) record. The listed applicant is Neural Analytics, Inc.. It received FDA 510(k) clearance on 2016-10-21 under 510(k) number K160442. 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 Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers?

Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is Neural Analytics, Inc.. The 510(k) number is K160442.

When did Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers receive FDA 510(k) clearance?

Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers received FDA 510(k) clearance on 2016-10-21, under 510(k) number K160442.

Who is the listed applicant for Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers?

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

What is the FDA product code for Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers?

The FDA product code for Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers is IYN.

Ensayos clínicos relacionados

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Otros registros que enlistan a Neural Analytics, Inc. como solicitante

K180455NeuralBot

Dispositivos relacionados (Código: IYN)

Fuente oficial

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