FDA 510(k)

Sterisystem 干基仪器托盘

K号: K203177 · 2022-01-02

决定日期2022-01-02

产品代码KCT

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决定实质等同

器械摘要

Sterisystem Dry-Base Instrument Tray is the device name listed in this FDA 510(k) record. The listed applicant is O&M Halyard, Inc.. It received FDA 510(k) clearance on 2022-01-02 under 510(k) number K203177. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sterisystem Dry-Base Instrument Tray?

Sterisystem Dry-Base Instrument Tray is a medical device that received FDA 510(k) clearance on 2022-01-02. The listed applicant is O&M Halyard, Inc.. The 510(k) number is K203177.

When did Sterisystem Dry-Base Instrument Tray receive FDA 510(k) clearance?

Sterisystem Dry-Base Instrument Tray received FDA 510(k) clearance on 2022-01-02, under 510(k) number K203177.

Who is the listed applicant for Sterisystem Dry-Base Instrument Tray?

FDA 510(k)记录中列出O&M Halyard, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Sterisystem Dry-Base Instrument Tray?

The FDA product code for Sterisystem Dry-Base Instrument Tray is KCT.

列明O&M Halyard, Inc.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。

K262014PUREZERO* MARIN* 硅橡胶无粉检查手套；PUREZERO* MARIN-XTRA* 硅橡胶无粉检查手套 K261897HALYARD* ARMOR-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* HEAVY-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* STANDARD-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* H300W 消毒包裹带 ASSURE-DRY* 技术 K253454HALYARD* ONE-STEP* 消毒包裹；HALYARD* QUICK CHECK* 消毒包裹；HALYARD* SEQUENTIAL 消毒包裹；HALYARD* SMART-FOLD* 消毒包裹 K251967HALYARD* FLUIDSHIELD* 3 防雾程序口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带；HALYARD* FLUIDSHIELD* 3 防雾程序口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带，带有 WrapAround 护目镜 K252941HALYARD* 成人面部口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带 K243604Halyard紫色丁腈-XTRA*无粉手套，低皮炎潜力，用于化疗药物，芬太尼盐酸盐和模拟胃酸中的芬太尼盐酸盐

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