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

Thermometer, Electronic, Clinical

CIRCA Scientific, LLC

The following data is part of a premarket notification filed by Circa Scientific, Llc with the FDA for Circa S-cath M Esophageal Temperature Probe And Temperature Monitoring System.

Pre-market Notification Details

Device IDK200943
510k NumberK200943
Device Name:Circa S-Cath M Esophageal Temperature Probe And Temperature Monitoring System
ClassificationThermometer, Electronic, Clinical
Applicant CIRCA Scientific, LLC 14 Inverness Drive East, Suite H-136 Englewood,  CO  80112
ContactFred Piazza
CorrespondentFred Piazza
CIRCA Scientific, LLC 14 Inverness Drive East, Suite H-136 Englewood,  CO  80112
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-08
Decision Date2021-12-17

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.