ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
K-Number: K192210 · 2019-10-10
ApplicantFiab Spa
Decision Date2019-10-10
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 2019-10-10 under approval number K192210. 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 2019-10-10. It is manufactured by Fiab Spa. The 510(k) number is K192210.
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 2019-10-10, under approval number K192210.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.