FDA 510(k)

Acumen Hypotension Prediction Index, HemoSphere Fortgeschrittene Überwachungsplattform

K-Nummer: K203224 · 2021-07-30

Entscheidungsdatum2021-07-30

ProduktcodeQAQ

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K203224. The device is classified under product code QAQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform?

Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K203224.

When did Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform receive FDA 510(k) clearance?

Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform received FDA 510(k) clearance on 2021-07-30, under 510(k) number K203224.

Who is the listed applicant for Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform?

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

What is the FDA product code for Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform?

The FDA product code for Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform is QAQ.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

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

Weitere Einträge mit Edwards Lifesciences, LLC als Antragsteller

K251326Respiration Rate algorithm K253186HemoSphere Nano Monitor (HSNANO1)K251982Edwards MC3 Tricuspid annuloplasty ring (4900)K251688Carpentier-Edwards Physio Annuloplasty Ring (4450)K242518Hypertension Prediction Index (HePI) Algorithm K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors

Alle 53 Geräte anzeigen →

Verwandte Geräte (Code: QAQ)

K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC K183646Acumen Hypotension Prediction Index – EV1000 Klinische Plattform, Acumen Hypotension Prediction Index – HemoSphere Fortgeschrittene Überwachungsplattform, Acumen Hypotension Prediction Index – HemoSphere Fortgeschrittene Überwachungsplattform - DruckEdwards Lifeciences, LLC

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.