FDA 510(k)

Patient Monitoring Cable (SpO2 Extension Cable)

Numéro K : K192404 · 2020-06-22

DemandeurShenzhen Coreray Technology, Ltd.

Date de décision2020-06-22

Code produitDSA

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Patient Monitoring Cable (SpO2 Extension Cable) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Coreray Technology, Ltd.. It received FDA 510(k) clearance on 2020-06-22 under 510(k) number K192404. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Patient Monitoring Cable (SpO2 Extension Cable)?

Patient Monitoring Cable (SpO2 Extension Cable) is a medical device that received FDA 510(k) clearance on 2020-06-22. The listed applicant is Shenzhen Coreray Technology, Ltd.. The 510(k) number is K192404.

When did Patient Monitoring Cable (SpO2 Extension Cable) receive FDA 510(k) clearance?

Patient Monitoring Cable (SpO2 Extension Cable) received FDA 510(k) clearance on 2020-06-22, under 510(k) number K192404.

Who is the listed applicant for Patient Monitoring Cable (SpO2 Extension Cable)?

The FDA 510(k) record lists Shenzhen Coreray Technology, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Patient Monitoring Cable (SpO2 Extension Cable)?

The FDA product code for Patient Monitoring Cable (SpO2 Extension Cable) is DSA.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Autres dossiers indiquant Shenzhen Coreray Technology, Ltd. en tant que demandeur

K173368Reusable & Disposable SpO2 Sensors K172797ECG Cable/Leadwires

Dispositifs connexes (Code : DSA)

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.