FDA 510(k)

Modular Toga

N.º K: K200977 · 2020-08-05

SolicitanteOperating Room Innovations, Inc.

Fecha de decisión2020-08-05

Código de productoFYA

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Modular Toga is the device name listed in this FDA 510(k) record. The listed applicant is Operating Room Innovations, Inc.. It received FDA 510(k) clearance on 2020-08-05 under 510(k) number K200977. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Modular Toga?

Modular Toga is a medical device that received FDA 510(k) clearance on 2020-08-05. The listed applicant is Operating Room Innovations, Inc.. The 510(k) number is K200977.

When did Modular Toga receive FDA 510(k) clearance?

Modular Toga received FDA 510(k) clearance on 2020-08-05, under 510(k) number K200977.

Who is the listed applicant for Modular Toga?

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

What is the FDA product code for Modular Toga?

The FDA product code for Modular Toga is FYA.

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Fuente oficial

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