闭塞性检测敷料套装
K号: K171499 · 2017-09-22
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器械摘要
Occlusion Detection Dressing Kit is the device name listed in this FDA 510(k) record. The listed applicant is Cardinalhealth. It received FDA 510(k) clearance on 2017-09-22 under 510(k) number K171499. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Occlusion Detection Dressing Kit?
Occlusion Detection Dressing Kit is a medical device that received FDA 510(k) clearance on 2017-09-22. The listed applicant is Cardinalhealth. The 510(k) number is K171499.
When did Occlusion Detection Dressing Kit receive FDA 510(k) clearance?
Occlusion Detection Dressing Kit received FDA 510(k) clearance on 2017-09-22, under 510(k) number K171499.
Who is the listed applicant for Occlusion Detection Dressing Kit?
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 Occlusion Detection Dressing Kit?
The FDA product code for Occlusion Detection Dressing Kit is OMP.
相关临床试验
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。
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); MonojecK243652Monoject® 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)K230569Cardinal 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）K213174Salem Sump 硅胶双腔胃管带 ENFit 连接
相关器械（代码：OMP）
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。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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