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FDA 510(k)

CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System

K-Number: K222311 · 2023-05-25

ApplicantCirca Scientific, Inc.
Decision Date2023-05-25
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System is a medical device manufactured by Circa Scientific, Inc.. It received FDA 510(k) clearance on 2023-05-25 under approval number K222311. 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 MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System?

CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System is a medical device that received FDA 510(k) clearance on 2023-05-25. It is manufactured by Circa Scientific, Inc.. The 510(k) number is K222311.

When was CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System approved by the FDA?

CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System received FDA 510(k) clearance on 2023-05-25, under approval number K222311.

What company makes CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System?

CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System is manufactured by Circa Scientific, Inc..

What is the FDA product code for CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System?

The FDA product code for CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System is FLL.

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Other Devices by Circa Scientific, Inc.

K243193Cross Wise™ Multi-Use RF Adapter Cable K241414CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) K240004CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer K251007CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) K243954PeriCross™ Epicardial Access Kit

Related Devices (Code: FLL)

K160306Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd. K161728Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1Microfile Intellectual Property GmbH K161735Non-contact Forehead ThermometerShenzhen Dongdixin Technology Co., Ltd. K160816Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)Nexmed Technology Co., Ltd. K161211Digital ThermometerBiocare Asia Corporation , Ltd. K160802Infrared Forehead Thermometer, FT-100AHangzhou Universal Electronic Co., Ltd.

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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