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FDA 510(k)

飛利浦穿戴式生物感測器-G5解決方案

K 號：K181165 · 2019-03-07

申請人Connected Sensing- A Division of Philips Medical Systems
決定日期2019-03-07
產品代碼DRT
諮詢委員會履歷
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

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相關器械（代碼：DRT）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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