FDA 510(k)

Philips wearable biosensor-G5 Solution

K-번호: K181165 · 2019-03-07

신청자Connected Sensing- A Division of Philips Medical Systems

결정일2019-03-07

제품 코드DRT

자문 위원회CV

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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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Philips wearable biosensor-G5 Solution

기기 요약

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관련 임상시험

관련 기기 (코드: DRT)

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