FDA 510(k)

Hydroven 12, Hydroven 12 衣物

K 號：K152228 · 2016-04-04

決定日期2016-04-04

產品代碼JOW

諮詢委員會履歷

決定相當於

器材摘要

Hydroven 12, Hydroven 12 Garments is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare , Ltd.. It received FDA 510(k) clearance on 2016-04-04 under 510(k) number K152228. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hydroven 12, Hydroven 12 Garments?

Hydroven 12, Hydroven 12 Garments is a medical device that received FDA 510(k) clearance on 2016-04-04. The listed applicant is Huntleigh Healthcare , Ltd.. The 510(k) number is K152228.

When did Hydroven 12, Hydroven 12 Garments receive FDA 510(k) clearance?

Hydroven 12, Hydroven 12 Garments received FDA 510(k) clearance on 2016-04-04, under 510(k) number K152228.

Who is the listed applicant for Hydroven 12, Hydroven 12 Garments?

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

What is the FDA product code for Hydroven 12, Hydroven 12 Garments?

The FDA product code for Hydroven 12, Hydroven 12 Garments is JOW.

其他以 Huntleigh Healthcare , Ltd. 為申請人之記錄

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相關器械（代碼：JOW）

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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