FDA 510(k)

IFM Surgical Mask Model SM3

Numéro K : K202214 · 2021-03-02

Date de décision2021-03-02

Code produitFXX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

IFM Surgical Mask Model SM3 is the device name listed in this FDA 510(k) record. The listed applicant is Fssc, LLC. It received FDA 510(k) clearance on 2021-03-02 under 510(k) number K202214. 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 IFM Surgical Mask Model SM3?

IFM Surgical Mask Model SM3 is a medical device that received FDA 510(k) clearance on 2021-03-02. The listed applicant is Fssc, LLC. The 510(k) number is K202214.

When did IFM Surgical Mask Model SM3 receive FDA 510(k) clearance?

IFM Surgical Mask Model SM3 received FDA 510(k) clearance on 2021-03-02, under 510(k) number K202214.

Who is the listed applicant for IFM Surgical Mask Model SM3?

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

What is the FDA product code for IFM Surgical Mask Model SM3?

The FDA product code for IFM Surgical Mask Model SM3 is FXX.

Essais cliniques associés

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Dispositifs connexes (Code : FXX)

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Source officielle

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