FDA 510(k)

Patient Cables and Leadwires , Disposable ECG Leadwires

Numéro K : K182327 · 2019-01-30

Date de décision2019-01-30

Code produitDSA

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Patient Cables and Leadwires , Disposable ECG Leadwires is the device name listed in this FDA 510(k) record. The listed applicant is Orantech, Inc.. It received FDA 510(k) clearance on 2019-01-30 under 510(k) number K182327. 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 Cables and Leadwires , Disposable ECG Leadwires?

Patient Cables and Leadwires , Disposable ECG Leadwires is a medical device that received FDA 510(k) clearance on 2019-01-30. The listed applicant is Orantech, Inc.. The 510(k) number is K182327.

When did Patient Cables and Leadwires , Disposable ECG Leadwires receive FDA 510(k) clearance?

Patient Cables and Leadwires , Disposable ECG Leadwires received FDA 510(k) clearance on 2019-01-30, under 510(k) number K182327.

Who is the listed applicant for Patient Cables and Leadwires , Disposable ECG Leadwires?

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

What is the FDA product code for Patient Cables and Leadwires , Disposable ECG Leadwires?

The FDA product code for Patient Cables and Leadwires , Disposable ECG Leadwires 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 Orantech, Inc. en tant que demandeur

K173194Temperature Probe K181270Disposable SpO2 Sensors, Reusable SpO2 Sensors K173197Reusable NIBP Cuff K171828ETCO2 Sensor

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.