FDA 510(k)

Phoenix Clinical ICON

Número K: K170527 · 2017-09-15

RequerentePhoenix Technology Group, Inc. Dba Phoenix Clinical

Data da decisão2017-09-15

Código do produtoHKI

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Phoenix Clinical ICON is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Technology Group, Inc. Dba Phoenix Clinical. It received FDA 510(k) clearance on 2017-09-15 under 510(k) number K170527. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Phoenix Clinical ICON?

Phoenix Clinical ICON is a medical device that received FDA 510(k) clearance on 2017-09-15. The listed applicant is Phoenix Technology Group, Inc. Dba Phoenix Clinical. The 510(k) number is K170527.

When did Phoenix Clinical ICON receive FDA 510(k) clearance?

Phoenix Clinical ICON received FDA 510(k) clearance on 2017-09-15, under 510(k) number K170527.

Who is the listed applicant for Phoenix Clinical ICON?

The FDA 510(k) record lists Phoenix Technology Group, Inc. Dba Phoenix Clinical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Phoenix Clinical ICON?

The FDA product code for Phoenix Clinical ICON is HKI.

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