FDA 510(k)

Poseidon Ultrasound System

N.º K: K163510 · 2017-09-06

Fecha de decisión2017-09-06

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Poseidon Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Butterfly Network, Inc.. It received FDA 510(k) clearance on 2017-09-06 under 510(k) number K163510. 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 Poseidon Ultrasound System?

Poseidon Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-09-06. The listed applicant is Butterfly Network, Inc.. The 510(k) number is K163510.

When did Poseidon Ultrasound System receive FDA 510(k) clearance?

Poseidon Ultrasound System received FDA 510(k) clearance on 2017-09-06, under 510(k) number K163510.

Who is the listed applicant for Poseidon Ultrasound System?

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

What is the FDA product code for Poseidon Ultrasound System?

The FDA product code for Poseidon Ultrasound System is IYN.

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Otros registros que enlistan a Butterfly Network, Inc. como solicitante

K252148Butterfly Gestational Age Tool K232808Butterfly iQ3 Ultrasound System K220068Butterfly iQ/iQ+ Ultrasound System K202406Butterfly iQ Ultrasound System K200980Auto 3D Bladder Volume Tool

Dispositivos relacionados (Código: IYN)

Fuente oficial

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