FDA 510(k)

JAZZ Passer 適用醫療設備規範文本

K 號：K171881 · 2017-08-08

決定日期2017-08-08

產品代碼OWI

諮詢委員會或

決定相當於

器材摘要

JAZZ Passer Band is the device name listed in this FDA 510(k) record. The listed applicant is Implanet, S.A.. It received FDA 510(k) clearance on 2017-08-08 under 510(k) number K171881. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the JAZZ Passer Band?

JAZZ Passer Band is a medical device that received FDA 510(k) clearance on 2017-08-08. The listed applicant is Implanet, S.A.. The 510(k) number is K171881.

When did JAZZ Passer Band receive FDA 510(k) clearance?

JAZZ Passer Band received FDA 510(k) clearance on 2017-08-08, under 510(k) number K171881.

Who is the listed applicant for JAZZ Passer Band?

The FDA 510(k) record lists Implanet, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JAZZ Passer Band?

The FDA product code for JAZZ Passer Band is OWI.

其他以 Implanet, S.A. 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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相關器械（代碼：OWI）

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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