FDA 510(k)

海麗感測器

K 號：K182573 · 2019-06-07

決定日期2019-06-07

產品代碼CAF

諮詢委員會AN

決定相當於

器材摘要

Hailie Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Adherium (Nz), Ltd.. It received FDA 510(k) clearance on 2019-06-07 under 510(k) number K182573. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hailie Sensor?

Hailie Sensor is a medical device that received FDA 510(k) clearance on 2019-06-07. The listed applicant is Adherium (Nz), Ltd.. The 510(k) number is K182573.

When did Hailie Sensor receive FDA 510(k) clearance?

Hailie Sensor received FDA 510(k) clearance on 2019-06-07, under 510(k) number K182573.

Who is the listed applicant for Hailie Sensor?

The FDA 510(k) record lists Adherium (Nz), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hailie Sensor?

The FDA product code for Hailie Sensor is CAF.

其他以 Adherium (Nz), Ltd. 為申請人之記錄

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相關器械（代碼：CAF）

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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