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FDA 510(k)

ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System

K-Number: K180047 · 2018-11-08

ApplicantFiab Spa
Decision Date2018-11-08
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System is a medical device manufactured by Fiab Spa. It received FDA 510(k) clearance on 2018-11-08 under approval number K180047. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Fiab Spa. The 510(k) number is K180047.

When was ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System approved by the FDA?

ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System received FDA 510(k) clearance on 2018-11-08, under approval number K180047.

What company makes ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System?

ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System is manufactured by Fiab Spa.

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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Official Source

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