FDA 510(k)

硬脊膜外麻醉針，脊椎麻醉針，綜合麻醉針

K 號：K171518 · 2018-01-05

申請人Zhejiang Kindly Medical Devices Co., Ltd.

決定日期2018-01-05

產品代碼BSP

諮詢委員會AN

決定相當於

器材摘要

Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Kindly Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2018-01-05 under 510(k) number K171518. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles?

Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles is a medical device that received FDA 510(k) clearance on 2018-01-05. The listed applicant is Zhejiang Kindly Medical Devices Co., Ltd.. The 510(k) number is K171518.

When did Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles receive FDA 510(k) clearance?

Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles received FDA 510(k) clearance on 2018-01-05, under 510(k) number K171518.

Who is the listed applicant for Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles?

The FDA 510(k) record lists Zhejiang Kindly Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles?

The FDA product code for Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles is BSP.

其他以 Zhejiang Kindly Medical Devices Co., Ltd. 為申請人之記錄

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相關器械（代碼：BSP）

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。

K243690SonoMSKPAJUNK GmbH Medizintechnologie K243682SonoPlex STIM；SonoPlex IIPAJUNK GmbH Medizintechnologie K250774SPROTTE® 标準 (LUER/NRFit®) 腰椎穿刺PAJUNK GmbH Medizintechnologie K243525SonoTAP 及 SonoTAP IIPAJUNK GmbH Medizintechnologie K241953SPROTTE®標準（LUER/NRFit®）麻醉學PAJUNK GmbH Medizintechnologie K241954SonoBlock；SonoBlock IIPAJUNK GmbH Medizintechnologie

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