FDA 510(k)

ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System

Número K: K180047 · 2018-11-08

Data da decisão2018-11-08

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do 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 2018-11-08 under 510(k) number K180047. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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 2018-11-08. The listed applicant is Fiab Spa. The 510(k) number is K180047.

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 2018-11-08, under 510(k) number K180047.

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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Outros registros que listam Fiab Spa como candidato(a)

K192210ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System

Dispositivos Relacionados (Código: FLL)

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