FDA 510(k)

Healy

K 號：K191075 · 2019-11-22

決定日期2019-11-22

產品代碼NUH

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Healy is the device name listed in this FDA 510(k) record. The listed applicant is Timewaver Production GmbH. It received FDA 510(k) clearance on 2019-11-22 under 510(k) number K191075. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Healy?

Healy is a medical device that received FDA 510(k) clearance on 2019-11-22. The listed applicant is Timewaver Production GmbH. The 510(k) number is K191075.

When did Healy receive FDA 510(k) clearance?

Healy received FDA 510(k) clearance on 2019-11-22, under 510(k) number K191075.

Who is the listed applicant for Healy?

The FDA 510(k) record lists Timewaver Production GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Healy?

The FDA product code for Healy is NUH.

其他以 Timewaver Production GmbH 為申請人之記錄

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K212832時波器頻率

相關器械（代碼：NUH）

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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