Avertissement: Ce site agrège des données publiques officielles provenant de la FDA, ClinicalTrials.gov, PubMed et SEC EDGAR à titre de référence générale uniquement. Il ne constitue pas un avis médical, un diagnostic, une recommandation de traitement ni un conseil en investissement.

FDA 510(k)

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

Numéro K : K200943 · 2021-12-17

DemandeurCirca Scientific, LLC
Date de décision2021-12-17
Code produitFLL
Comité consultatifHO
DécisionSubstantially Equivalent

Résumé du dispositif

Circa S-Cath 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, LLC. It received FDA 510(k) clearance on 2021-12-17 under 510(k) number K200943. 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 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. The listed applicant is Circa Scientific, LLC. The 510(k) number is K200943.

When did Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System receive FDA 510(k) clearance?

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

Who is the listed applicant for Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System?

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

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.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.

↑