FDA 510(k)

Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra

N.º K: K161162 · 2016-09-16

Fecha de decisión2016-09-16

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra is the device name listed in this FDA 510(k) record. The listed applicant is Ellipse A/S. It received FDA 510(k) clearance on 2016-09-16 under 510(k) number K161162. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra?

Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra is a medical device that received FDA 510(k) clearance on 2016-09-16. The listed applicant is Ellipse A/S. The 510(k) number is K161162.

When did Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra receive FDA 510(k) clearance?

Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra received FDA 510(k) clearance on 2016-09-16, under 510(k) number K161162.

Who is the listed applicant for Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra?

The FDA 510(k) record lists Ellipse A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra?

The FDA product code for Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra is GEX. This falls under the Gastroenterology category.

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Otros registros que enlistan a Ellipse A/S como solicitante

K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun K180406Ellipse Ydun

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Fuente oficial

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