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FDA 510(k)

CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System

Numéro K : K222311 · 2023-05-25

DemandeurCirca Scientific, Inc.
Date de décision2023-05-25
Code produitFLL
Comité consultatifHO
DécisionSubstantially Equivalent

Résumé du dispositif

CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Circa Scientific, Inc.. It received FDA 510(k) clearance on 2023-05-25 under 510(k) number K222311. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Circa Scientific, Inc.. The 510(k) number is K222311.

When did CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System receive FDA 510(k) clearance?

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

Who is the listed applicant for CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System?

The FDA 510(k) record lists Circa Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Autres dossiers indiquant Circa Scientific, Inc. en tant que demandeur

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

K251007CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)K243954PeriCross™ Epicardial Access KitK243193Cross Wise™ Multi-Use RF Adapter CableK241414CrossWise 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

Dispositifs connexes (Code : FLL)

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)Unimed Medical Supplies, Inc.K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd.K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd.K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd.K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., Ltd.

Source officielle

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