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FDA 510(k)

穿戴式設備，附帶Homehub的居家包裝盒，不含Homehub的居家包裝盒

K 號：K190073 · 2019-03-27

申請人Current Health , Ltd.
決定日期2019-03-27
產品代碼MSX
諮詢委員會履歷
決定相當於

器材摘要

Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub is the device name listed in this FDA 510(k) record. The listed applicant is Current Health , Ltd.. It received FDA 510(k) clearance on 2019-03-27 under 510(k) number K190073. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub?

Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub is a medical device that received FDA 510(k) clearance on 2019-03-27. The listed applicant is Current Health , Ltd.. The 510(k) number is K190073.

When did Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub receive FDA 510(k) clearance?

Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub received FDA 510(k) clearance on 2019-03-27, under 510(k) number K190073.

Who is the listed applicant for Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub?

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

What is the FDA product code for Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub?

The FDA product code for Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub is MSX.

相關臨床試驗

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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其他以 Current Health , Ltd. 為申請人之記錄

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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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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