FDA 510(k)

Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)

K 號：K252746 · 2026-05-21

決定日期2026-05-21

產品代碼BSZ

諮詢委員會AN

決定相當於

器材摘要

Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) is the device name listed in this FDA 510(k) record. The listed applicant is Drägerwerk AG Co. Kgaa. It received FDA 510(k) clearance on 2026-05-21 under 510(k) number K252746. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)?

Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is Drägerwerk AG Co. Kgaa. The 510(k) number is K252746.

When did Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) receive FDA 510(k) clearance?

Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) received FDA 510(k) clearance on 2026-05-21, under 510(k) number K252746.

Who is the listed applicant for Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)?

The FDA 510(k) record lists Drägerwerk AG Co. Kgaa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)?

The FDA product code for Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) is BSZ.

其他以 Drägerwerk AG Co. Kgaa 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。

K230931Atlan

相關器械（代碼：BSZ）

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。

K253330A5 麻醉系統 (A5)；A7 麻醉系統 (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K251352Codonics 安全標籤系統-臨床工作站 (PCS) (SLS-700i 及相關 610i、620i、630i 系列已啟用安裝 RFID 功能)；Codonics 安全標籤系統-臨床工作站 (PCS) (SLS-1、SLS XXX、多款型號待配置中)Codonics.Incorporated K230931AtlanDrägerwerk AG Co. Kgaa K213867Carestation 750/750cDatex-Ohmeda, Inc.K201957A8, A9 麻醉系統Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K191027Flow-i 麻醉系統，Flow-c 麻醉系統，Flow-e 麻醉系統Maquet Critical Care AB

官方來源

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