FDA 510(k)

3M Masque Chirurgicaux à Haute Performance, 3M Masque Chirurgicaux à Haute Performance avec Visière de Visage

Numéro K : K180874 · 2018-07-31

Date de décision2018-07-31

Code produitFXX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare. It received FDA 510(k) clearance on 2018-07-31 under 510(k) number K180874. 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 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield?

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield is a medical device that received FDA 510(k) clearance on 2018-07-31. The listed applicant is 3M Healthcare. The 510(k) number is K180874.

When did 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield receive FDA 510(k) clearance?

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield received FDA 510(k) clearance on 2018-07-31, under 510(k) number K180874.

Who is the listed applicant for 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield?

The FDA 510(k) record lists 3M Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield?

The FDA product code for 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield is FXX.

Essais cliniques associés

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Autres dossiers indiquant 3M Healthcare en tant que demandeur

K1931103M Attest Vaporisé Hydrogène Peroxyde Tri-Métrique Indicateur Chimique 1348/1348E K1913553M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask K1804043M Clarity Ultra Brides Auto-Ligantes et Système d'Appareil Collant Revêtu d'Adhésif K1711163M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Models 1804/1804S K153571Cavilon Advanced High Endurance Skin Protectant

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

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