FDA 510(k)

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus

K号: K221836 · 2022-12-07

决定日期2022-12-07

产品代码CAH

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决定实质等同

器械摘要

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus 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 2022-12-07 under 510(k) number K221836. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus?

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus is a medical device that received FDA 510(k) clearance on 2022-12-07. The listed applicant is Drägerwerk AG & Co. KGaA. The 510(k) number is K221836.

When did Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus receive FDA 510(k) clearance?

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus received FDA 510(k) clearance on 2022-12-07, under 510(k) number K221836.

Who is the listed applicant for Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus?

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 Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus?

The FDA product code for Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus is CAH.

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。

K251619Babyleo TN500 K252827IBP电缆Becton Dickinson（2606488）；IBP电缆Edwards（2606489）；IBP电缆Abbott, Medex（2606490）；IBP电缆Utah（2606491）；IBP适配器电缆Draeger 7针（2607558）；IBP适配器电缆Draeger 10针（2607559）

官方来源

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