FDA 510(k)

IDSS ForceTriad Control Module

Número K: K153205 · 2016-08-01

Data da decisão2016-08-01

Código do produtoODA

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

IDSS ForceTriad Control Module is the device name listed in this FDA 510(k) record. The listed applicant is Black Diamond Video, Inc.. It received FDA 510(k) clearance on 2016-08-01 under 510(k) number K153205. The device is classified under product code ODA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the IDSS ForceTriad Control Module?

IDSS ForceTriad Control Module is a medical device that received FDA 510(k) clearance on 2016-08-01. The listed applicant is Black Diamond Video, Inc.. The 510(k) number is K153205.

When did IDSS ForceTriad Control Module receive FDA 510(k) clearance?

IDSS ForceTriad Control Module received FDA 510(k) clearance on 2016-08-01, under 510(k) number K153205.

Who is the listed applicant for IDSS ForceTriad Control Module?

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

What is the FDA product code for IDSS ForceTriad Control Module?

The FDA product code for IDSS ForceTriad Control Module is ODA.

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