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FDA 510(k)

Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System

K-Number: K200943 · 2021-12-17

ApplicantCirca Scientific, LLC
Decision Date2021-12-17
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System is a medical device manufactured by Circa Scientific, LLC. It received FDA 510(k) clearance on 2021-12-17 under approval number K200943. 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 Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System?

Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System is a medical device that received FDA 510(k) clearance on 2021-12-17. It is manufactured by Circa Scientific, LLC. The 510(k) number is K200943.

When was Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System approved by the FDA?

Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System received FDA 510(k) clearance on 2021-12-17, under approval number K200943.

What company makes Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System?

Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System is manufactured by Circa Scientific, LLC.

What is the FDA product code for Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System?

The FDA product code for Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System is FLL.

Related Clinical Trials

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Related PubMed Literature

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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.

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