FDA 510(k)

Capteurs dentaires Apex

Numéro K : K163282 · 2017-02-28

Date de décision2017-02-28

Code produitMUH

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

Apex Dental Sensors is the device name listed in this FDA 510(k) record. The listed applicant is Masterlink, LLC. It received FDA 510(k) clearance on 2017-02-28 under 510(k) number K163282. 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 Apex Dental Sensors?

Apex Dental Sensors is a medical device that received FDA 510(k) clearance on 2017-02-28. The listed applicant is Masterlink, LLC. The 510(k) number is K163282.

When did Apex Dental Sensors receive FDA 510(k) clearance?

Apex Dental Sensors received FDA 510(k) clearance on 2017-02-28, under 510(k) number K163282.

Who is the listed applicant for Apex Dental Sensors?

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

What is the FDA product code for Apex Dental Sensors?

The FDA product code for Apex Dental Sensors is MUH.

Essais cliniques associés

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Dispositifs connexes (Code : MUH)

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Source officielle

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