FDA 510(k)

Philips wearable biosensor-G5 Solution

Número K: K181165 · 2019-03-07

RequerenteConnected Sensing- A Division of Philips Medical Systems

Data da decisão2019-03-07

Código do produtoDRT

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Philips wearable biosensor-G5 Solution is the device name listed in this FDA 510(k) record. The listed applicant is Connected Sensing- A Division of Philips Medical Systems. It received FDA 510(k) clearance on 2019-03-07 under 510(k) number K181165. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Philips wearable biosensor-G5 Solution?

Philips wearable biosensor-G5 Solution is a medical device that received FDA 510(k) clearance on 2019-03-07. The listed applicant is Connected Sensing- A Division of Philips Medical Systems. The 510(k) number is K181165.

When did Philips wearable biosensor-G5 Solution receive FDA 510(k) clearance?

Philips wearable biosensor-G5 Solution received FDA 510(k) clearance on 2019-03-07, under 510(k) number K181165.

Who is the listed applicant for Philips wearable biosensor-G5 Solution?

The FDA 510(k) record lists Connected Sensing- A Division of Philips Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips wearable biosensor-G5 Solution?

The FDA product code for Philips wearable biosensor-G5 Solution is DRT.

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