FDA 510(k)

Index de prédiction de l'hypotension (HPI), Plateforme de surveillance avancée HemoSphere

Numéro K : K203224 · 2021-07-30

Date de décision2021-07-30

Code produitQAQ

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

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 Edwards Lifesciences, LLC en tant que demandeur

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

Voir tous les 53 dispositifs →

Dispositifs connexes (Code : QAQ)

K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC K230057Algorithme de prédiction de l'hypotension (HPI) AcumenEdwards Lifesciences, LLC K183646Index de prédiction de l'hypotension (HPI) - Plateforme clinique EV1000 Acumen, Index de prédiction de l'hypotension (HPI) - Plateforme de surveillance avancée HemoSphere, Index de prédiction de l'hypotension (HPI) - Plateforme de surveillance avancée HemoSphere - PressionEdwards Lifeciences, LLC

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.