FDA 510(k)

TEETHAN 2.0

Número K: K161716 · 2016-12-21

Data da decisão2016-12-21

Código do produtoKZM

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

TEETHAN 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Bts S.P.A.. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K161716. The device is classified under product code KZM. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TEETHAN 2.0?

TEETHAN 2.0 is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Bts S.P.A.. The 510(k) number is K161716.

When did TEETHAN 2.0 receive FDA 510(k) clearance?

TEETHAN 2.0 received FDA 510(k) clearance on 2016-12-21, under 510(k) number K161716.

Who is the listed applicant for TEETHAN 2.0?

The FDA 510(k) record lists Bts S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEETHAN 2.0?

The FDA product code for TEETHAN 2.0 is KZM.

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