FDA 510(k)

Anspach Helix 分離工具

K 號：K183545 · 2019-07-19

決定日期2019-07-19

產品代碼HBE

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

Anspach Helix Dissection Tools is the device name listed in this FDA 510(k) record. The listed applicant is The Anspach Effort, Inc.. It received FDA 510(k) clearance on 2019-07-19 under 510(k) number K183545. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Anspach Helix Dissection Tools?

Anspach Helix Dissection Tools is a medical device that received FDA 510(k) clearance on 2019-07-19. The listed applicant is The Anspach Effort, Inc.. The 510(k) number is K183545.

When did Anspach Helix Dissection Tools receive FDA 510(k) clearance?

Anspach Helix Dissection Tools received FDA 510(k) clearance on 2019-07-19, under 510(k) number K183545.

Who is the listed applicant for Anspach Helix Dissection Tools?

The FDA 510(k) record lists The Anspach Effort, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anspach Helix Dissection Tools?

The FDA product code for Anspach Helix Dissection Tools is HBE.

其他以 The Anspach Effort, Inc. 為申請人之記錄

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K220485無線手控器，EG1A（WIRELESS-HC），無線手控器接收器，EG1A（RECEIVER-HC）K180063OCM-G1 附加檔

相關器械（代碼：HBE）

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。

官方來源

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