FDA 510(k)

血液輸送配件（BTA）

K 號：K181743 · 2019-07-30

決定日期2019-07-30

產品代碼JKA

諮詢委員會CH

決定相當於

器材摘要

Blood Transfer Accessory (BTA) 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 2019-07-30 under 510(k) number K181743. 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 Blood Transfer Accessory (BTA)?

Blood Transfer Accessory (BTA) is a medical device that received FDA 510(k) clearance on 2019-07-30. The listed applicant is Nsp Tech Pte, Ltd.. The 510(k) number is K181743.

When did Blood Transfer Accessory (BTA) receive FDA 510(k) clearance?

Blood Transfer Accessory (BTA) received FDA 510(k) clearance on 2019-07-30, under 510(k) number K181743.

Who is the listed applicant for Blood Transfer Accessory (BTA)?

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 Blood Transfer Accessory (BTA)?

The FDA product code for Blood Transfer Accessory (BTA) is JKA.

其他以 Nsp Tech Pte, 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。

K221783安全CET 安全針頭 K221604SafetiHeel、MediHeel、Novaplus K193074斜角固定器 K181754血液收集配件（BUCA）

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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