FDA 510(k)

电动+肠内营养系统OTC

K号: K233034 · 2024-04-12

决定日期2024-04-12

产品代码PIF

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决定实质等同

器械摘要

Mobility+ Enteral Feeding System OTC is the device name listed in this FDA 510(k) record. The listed applicant is Rockfield Medical. It received FDA 510(k) clearance on 2024-04-12 under 510(k) number K233034. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Mobility+ Enteral Feeding System OTC?

Mobility+ Enteral Feeding System OTC is a medical device that received FDA 510(k) clearance on 2024-04-12. The listed applicant is Rockfield Medical. The 510(k) number is K233034.

When did Mobility+ Enteral Feeding System OTC receive FDA 510(k) clearance?

Mobility+ Enteral Feeding System OTC received FDA 510(k) clearance on 2024-04-12, under 510(k) number K233034.

Who is the listed applicant for Mobility+ Enteral Feeding System OTC?

The FDA 510(k) record lists Rockfield Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mobility+ Enteral Feeding System OTC?

The FDA product code for Mobility+ Enteral Feeding System OTC is PIF.

列明Rockfield Medical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。

K222678电动+肠内营养系统

相关器械（代码：PIF）

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。

K260110丹诺美德胃造口按钮延长套件Danumed Medizintechnik GmbH K253715Edi 导管 ENFit 6Fr/48 cm (6893166)；Edi 导管 ENFit 6Fr/49cm (6893273)；Edi 导管 ENFit 6Fr/50cm (6893274)；Edi 导管 ENFit 8Fr/50cm (6893275)；Edi 导管 ENFit 8Fr/100cm (6893276)；Edi 导管 ENFit 8Fr/125cm (6893277)；Edi 导管 ENFit 12Fr/125cm (6893278)；Edi 导管 ENFit 16Fr/125cm (6893279)Maquet Critical Care AB K254170经皮内镜胃造瘘术（PEG）套件Degania Silicone , Ltd.K242917肠内引流系统，肠内药物吸管HMC Premedical S.p.A.K250481带ENFit®连接器的扩展输注套装SKY Medical, a.s.K240052一次性肠内营养喂养套装Beijing L&Z Medical Technology Development Co., Ltd.

官方来源

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