FDA 510(k)

Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip

Numéro K : K192374 · 2019-12-02

Date de décision2019-12-02

Code produitFXX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health200, LLC. It received FDA 510(k) clearance on 2019-12-02 under 510(k) number K192374. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip?

Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip is a medical device that received FDA 510(k) clearance on 2019-12-02. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K192374.

When did Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip receive FDA 510(k) clearance?

Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip received FDA 510(k) clearance on 2019-12-02, under 510(k) number K192374.

Who is the listed applicant for Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip?

The FDA 510(k) record lists Cardinal Health200, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip?

The FDA product code for Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip is FXX.

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 Cardinal Health200, LLC en tant que demandeur

K241780Cardinal Health Nitrile Exam Gloves K230838Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets K223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)K230028Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly K201592Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove K211390Nitrile Blue Powder-free Examination Glove

Voir tous les 14 dispositifs →

Dispositifs connexes (Code : FXX)

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

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.