FDA 510(k)

AIC masque médical à usage unique

Numéro K : K203775 · 2021-03-12

DemandeurThe Aleen International Corporation

Date de décision2021-03-12

Code produitFXX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

AIC disposable medical mask is the device name listed in this FDA 510(k) record. The listed applicant is The Aleen International Corporation. It received FDA 510(k) clearance on 2021-03-12 under 510(k) number K203775. 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 AIC disposable medical mask?

AIC disposable medical mask is a medical device that received FDA 510(k) clearance on 2021-03-12. The listed applicant is The Aleen International Corporation. The 510(k) number is K203775.

When did AIC disposable medical mask receive FDA 510(k) clearance?

AIC disposable medical mask received FDA 510(k) clearance on 2021-03-12, under 510(k) number K203775.

Who is the listed applicant for AIC disposable medical mask?

The FDA 510(k) record lists The Aleen International Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIC disposable medical mask?

The FDA product code for AIC disposable medical mask 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.

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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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