FDA 510(k)

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

K号: K252746 · 2026-05-21

决定日期2026-05-21

产品代码BSZ

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Drägerwerk AG Co. Kgaa为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K230931Atlan

相关器械（代码：BSZ）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253330A5 麻醉系统（A5）；A7 麻醉系统（A7）Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K251352Codonics安全标签系统-护理点工作站（PCS）（SLS-700i和相关610i、620i、630i系列启用RFID功能）；Codonics安全标签系统-护理点工作站（PCS）（SLS-1，SLS XXX，多个型号待配置）Codonics.Incorporated K230931AtlanDrägerwerk AG Co. Kgaa K213867Carestation 750/750cDatex-Ohmeda, Inc.K201957A8, A9 麻醉系统Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K191027Flow-i 麻醉系统，Flow-c 麻醉系统，Flow-e 麻醉系统Maquet Critical Care AB

官方来源

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