FDA 510(k)

Heartland Health Surgical Mask

Numéro K : K212366 · 2022-02-19

Date de décision2022-02-19

Code produitFXX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Heartland Health Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Heartland Health Products. It received FDA 510(k) clearance on 2022-02-19 under 510(k) number K212366. 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 Heartland Health Surgical Mask?

Heartland Health Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-02-19. The listed applicant is Heartland Health Products. The 510(k) number is K212366.

When did Heartland Health Surgical Mask receive FDA 510(k) clearance?

Heartland Health Surgical Mask received FDA 510(k) clearance on 2022-02-19, under 510(k) number K212366.

Who is the listed applicant for Heartland Health Surgical Mask?

The FDA 510(k) record lists Heartland Health Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Heartland Health Surgical Mask?

The FDA product code for Heartland Health Surgical 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)

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Source officielle

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