FDA 510(k)

Monarch Endoscopy Platform (Monarch Platform)

Número K: K173760 · 2018-03-22

Data da decisão2018-03-22

Código do produtoEOQ

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Monarch Endoscopy Platform (Monarch Platform) is the device name listed in this FDA 510(k) record. The listed applicant is Auris Surgical Robotics, Inc.. It received FDA 510(k) clearance on 2018-03-22 under 510(k) number K173760. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Monarch Endoscopy Platform (Monarch Platform)?

Monarch Endoscopy Platform (Monarch Platform) is a medical device that received FDA 510(k) clearance on 2018-03-22. The listed applicant is Auris Surgical Robotics, Inc.. The 510(k) number is K173760.

When did Monarch Endoscopy Platform (Monarch Platform) receive FDA 510(k) clearance?

Monarch Endoscopy Platform (Monarch Platform) received FDA 510(k) clearance on 2018-03-22, under 510(k) number K173760.

Who is the listed applicant for Monarch Endoscopy Platform (Monarch Platform)?

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

What is the FDA product code for Monarch Endoscopy Platform (Monarch Platform)?

The FDA product code for Monarch Endoscopy Platform (Monarch Platform) is EOQ.

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Outros registros que listam Auris Surgical Robotics, Inc. como candidato(a)

K152319Auris Robotic Endoscopy System (ARES)

Dispositivos Relacionados (Código: EOQ)

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Fonte oficial

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