FDA 510(k)

Digital Intraoral Imaging Plate System

Numéro K : K192766 · 2019-12-05

Date de décision2019-12-05

Code produitMUH

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

Digital Intraoral Imaging Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Fsusen Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-12-05 under 510(k) number K192766. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Digital Intraoral Imaging Plate System?

Digital Intraoral Imaging Plate System is a medical device that received FDA 510(k) clearance on 2019-12-05. The listed applicant is Fsusen Technology Co., Ltd.. The 510(k) number is K192766.

When did Digital Intraoral Imaging Plate System receive FDA 510(k) clearance?

Digital Intraoral Imaging Plate System received FDA 510(k) clearance on 2019-12-05, under 510(k) number K192766.

Who is the listed applicant for Digital Intraoral Imaging Plate System?

The FDA 510(k) record lists Fsusen Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Intraoral Imaging Plate System?

The FDA product code for Digital Intraoral Imaging Plate System is MUH.

Essais cliniques associés

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Source officielle

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