FDA 510(k)

斜角固定器

K 號：K193074 · 2020-04-21

決定日期2020-04-21

產品代碼JKA

諮詢委員會CH

決定相當於

器材摘要

Bevel Up Holder is the device name listed in this FDA 510(k) record. The listed applicant is Nsp Tech Pte, Ltd.. It received FDA 510(k) clearance on 2020-04-21 under 510(k) number K193074. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bevel Up Holder?

Bevel Up Holder is a medical device that received FDA 510(k) clearance on 2020-04-21. The listed applicant is Nsp Tech Pte, Ltd.. The 510(k) number is K193074.

When did Bevel Up Holder receive FDA 510(k) clearance?

Bevel Up Holder received FDA 510(k) clearance on 2020-04-21, under 510(k) number K193074.

Who is the listed applicant for Bevel Up Holder?

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

What is the FDA product code for Bevel Up Holder?

The FDA product code for Bevel Up Holder is JKA.

其他以 Nsp Tech Pte, Ltd. 為申請人之記錄

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相關器械（代碼：JKA）

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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