FDA 510(k)

FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber

Numéro K : K240569 · 2024-11-21

Date de décision2024-11-21

Code produitCBF

Comité consultatifAN

DécisionSubstantially Equivalent

Résumé du dispositif

FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber is the device name listed in this FDA 510(k) record. The listed applicant is Fink Engineering Pty, Ltd.. It received FDA 510(k) clearance on 2024-11-21 under 510(k) number K240569. The device is classified under product code CBF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber?

FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber is a medical device that received FDA 510(k) clearance on 2024-11-21. The listed applicant is Fink Engineering Pty, Ltd.. The 510(k) number is K240569.

When did FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber receive FDA 510(k) clearance?

FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber received FDA 510(k) clearance on 2024-11-21, under 510(k) number K240569.

Who is the listed applicant for FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber?

The FDA 510(k) record lists Fink Engineering Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber?

The FDA product code for FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber is CBF.

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

Dispositifs connexes (Code : CBF)

K220290Revitalair 430+Us Hyperbaric Network K171899Revitalair 430FOxavita Srl K163109OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc.K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control SystemOxyheal Medical Systems, Inc.

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.