FDA 510(k)

Medline 开背式三级防护服

K号: K233526 · 2024-03-05

决定日期2024-03-05

产品代码QPC

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决定实质等同

器械摘要

Medline Open-back Level 3 Protective Gown is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2024-03-05 under 510(k) number K233526. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Medline Open-back Level 3 Protective Gown?

Medline Open-back Level 3 Protective Gown is a medical device that received FDA 510(k) clearance on 2024-03-05. The listed applicant is Medline Industries, LP. The 510(k) number is K233526.

When did Medline Open-back Level 3 Protective Gown receive FDA 510(k) clearance?

Medline Open-back Level 3 Protective Gown received FDA 510(k) clearance on 2024-03-05, under 510(k) number K233526.

Who is the listed applicant for Medline Open-back Level 3 Protective Gown?

FDA 510(k)记录显示Medline Industries, LP为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Medline Open-back Level 3 Protective Gown?

The FDA product code for Medline Open-back Level 3 Protective Gown is QPC.

列明Medline Industries, LP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。

K253526NAMIC 扩张器和套管 K254287Medline 可重复使用血压袖带 K253322Hudson RCI® 婴儿Dri-TechTM 呼吸回路（HUD99060 / Dri-Tech 婴儿回路，HUD99060KIT / Dri-Tech 婴儿回路套件，HUD99001KIT / 单肢婴儿回路Dri-Tech 套件，HUD99009KIT / Dri-Tech 婴儿回路套件，HUD99018KIT / Dri-Tech 婴儿回路套件，HUD870NKIT / Dri-Tech 婴儿附件袋，HUD1631 / 婴儿Y型连接器带旋转接头）K251687Konig 贝尔环状包皮环切夹 K253070Namic径向臂带，23厘米（DYNJRADBAND）；Namic径向臂带，26厘米（DYNJRADBANDL）K250345Medline 袋式过滤器

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官方来源

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