FDA 510(k)

HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable

N.º K: K223127 · 2022-11-07

Fecha de decisión2022-11-07

Código de productoDQK

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifeciences, LLC. It received FDA 510(k) clearance on 2022-11-07 under 510(k) number K223127. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable?

HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable is a medical device that received FDA 510(k) clearance on 2022-11-07. The listed applicant is Edwards Lifeciences, LLC. The 510(k) number is K223127.

When did HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable receive FDA 510(k) clearance?

HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable received FDA 510(k) clearance on 2022-11-07, under 510(k) number K223127.

Who is the listed applicant for HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable?

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

What is the FDA product code for HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable?

The FDA product code for HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable is DQK.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Otros registros que enlistan a Edwards Lifeciences, LLC como solicitante

K183646Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure K183413TruWave Disposable Pressure Transducer

Dispositivos relacionados (Código: DQK)

K261729EnSite™ X EP SystemAbbott Medical K262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott Medical K252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.