FDA 510(k)

ODI HD Dental Sensor

Número K: K190234 · 2019-03-01

Data da decisão2019-03-01

Código do produtoMUH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

ODI HD Dental Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Cnd Global Technologies, Inc.. It received FDA 510(k) clearance on 2019-03-01 under 510(k) number K190234. 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 ODI HD Dental Sensor?

ODI HD Dental Sensor is a medical device that received FDA 510(k) clearance on 2019-03-01. The listed applicant is Cnd Global Technologies, Inc.. The 510(k) number is K190234.

When did ODI HD Dental Sensor receive FDA 510(k) clearance?

ODI HD Dental Sensor received FDA 510(k) clearance on 2019-03-01, under 510(k) number K190234.

Who is the listed applicant for ODI HD Dental Sensor?

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

What is the FDA product code for ODI HD Dental Sensor?

The FDA product code for ODI HD Dental Sensor is MUH.

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