FDA 510(k)

TxTi IBF System

Número K: K183064 · 2019-06-28

Data da decisão2019-06-28

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

TxTi IBF System is the device name listed in this FDA 510(k) record. The listed applicant is Innovasis, Inc.. It received FDA 510(k) clearance on 2019-06-28 under 510(k) number K183064. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TxTi IBF System?

TxTi IBF System is a medical device that received FDA 510(k) clearance on 2019-06-28. The listed applicant is Innovasis, Inc.. The 510(k) number is K183064.

When did TxTi IBF System receive FDA 510(k) clearance?

TxTi IBF System received FDA 510(k) clearance on 2019-06-28, under 510(k) number K183064.

Who is the listed applicant for TxTi IBF System?

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

What is the FDA product code for TxTi IBF System?

The FDA product code for TxTi IBF System is MAX.

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Fonte oficial

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