FDA 510(k)

TIO-H DIGITAL RADIOGRAPHY SENSOR

Número K: K153144 · 2016-02-10

Data da decisão2016-02-10

Código do produtoMUH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

TIO-H DIGITAL RADIOGRAPHY SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Denttio, Inc.. It received FDA 510(k) clearance on 2016-02-10 under 510(k) number K153144. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TIO-H DIGITAL RADIOGRAPHY SENSOR?

TIO-H DIGITAL RADIOGRAPHY SENSOR is a medical device that received FDA 510(k) clearance on 2016-02-10. The listed applicant is Denttio, Inc.. The 510(k) number is K153144.

When did TIO-H DIGITAL RADIOGRAPHY SENSOR receive FDA 510(k) clearance?

TIO-H DIGITAL RADIOGRAPHY SENSOR received FDA 510(k) clearance on 2016-02-10, under 510(k) number K153144.

Who is the listed applicant for TIO-H DIGITAL RADIOGRAPHY SENSOR?

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

What is the FDA product code for TIO-H DIGITAL RADIOGRAPHY SENSOR?

The FDA product code for TIO-H DIGITAL RADIOGRAPHY SENSOR is MUH.

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