FDA 510(k)

Cardinal Health防雾水凝胶手术口罩（3级）；Cardinal Health防雾水凝胶手术口罩（1级）

K号: K230569 · 2023-07-03

决定日期2023-07-03

产品代码FXX

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决定实质等同

器械摘要

Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) is the device name listed in this FDA 510(k) record. The listed applicant is Cardinalhealth. It received FDA 510(k) clearance on 2023-07-03 under 510(k) number K230569. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )?

Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) is a medical device that received FDA 510(k) clearance on 2023-07-03. The listed applicant is Cardinalhealth. The 510(k) number is K230569.

When did Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) receive FDA 510(k) clearance?

Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) received FDA 510(k) clearance on 2023-07-03, under 510(k) number K230569.

Who is the listed applicant for Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )?

FDA 510(k)记录显示Cardinalhealth为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )?

The FDA product code for Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) is FXX.

列明Cardinalhealth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。

K261749Cardinal Health 硝基蓝检查手套，经测试可用于化疗药物和芬太尼盐酸盐使用 K252313Cardinal Health 氮化橡胶检查手套，延长袖口 K243660Monoject® 1mL 结核菌素注射器 Luer-Lock 尖端 (1180100777); Monoject® 3mL 注射器，Luer-Lock 尖端 (1180300777); Monoject® 6mL 注射器，Luer-Lock 尖端 (1180600777); Monoject® 12mL 注射器，Luer-Lock 尖端 (1181200777); Monoject® 20mL 注射器，Luer-Lock 尖端 (1182000777); Monoject® 35mL 注射器，Luer-Lock 尖端 (1183500777); Monoject® 60mL 注射器，Luer-Lock 尖端 (1186000777); Monoject® 3mL 注射器，Luer-Lock 尖端 (8881513934); Monoject® 6mL 注射器 , Luer-Lock 尖端 (8881516937); Monojec K243652Monoject® Enteral Syringe with ENFit Connector (401SE); Monoject® Enteral Syringe with ENFit Connector (403SE); Monoject® Enteral Syringe with ENFit Connector (406SE); Monoject® Enteral Syringe with ENFit Connector (412SE); Monoject® Enteral Syringe with ENFit Connector (435SE); Monoject® Enteral Syringe with ENFit Connector (460SE)K213174Salem Sump 硅胶双腔胃管带 ENFit 连接 K202217Kendall NPWT 切口管理设备

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官方来源

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