FDA 510(k)

ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System

N.º K: K192210 · 2019-10-10

Fecha de decisión2019-10-10

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Fiab Spa. It received FDA 510(k) clearance on 2019-10-10 under 510(k) number K192210. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System?

ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System is a medical device that received FDA 510(k) clearance on 2019-10-10. The listed applicant is Fiab Spa. The 510(k) number is K192210.

When did ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System receive FDA 510(k) clearance?

ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System received FDA 510(k) clearance on 2019-10-10, under 510(k) number K192210.

Who is the listed applicant for ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System?

The FDA 510(k) record lists Fiab Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System?

The FDA product code for ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System is FLL.

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Otros registros que enlistan a Fiab Spa como solicitante

K180047ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System

Dispositivos relacionados (Código: FLL)

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Fuente oficial

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