FDA 510(k)

Tablo药盒

K号: K210782 · 2021-11-26

决定日期2021-11-26

产品代码FJK

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决定实质等同

器械摘要

Tablo Cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Outset Medical, Inc.. It received FDA 510(k) clearance on 2021-11-26 under 510(k) number K210782. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tablo Cartridge?

Tablo Cartridge is a medical device that received FDA 510(k) clearance on 2021-11-26. The listed applicant is Outset Medical, Inc.. The 510(k) number is K210782.

When did Tablo Cartridge receive FDA 510(k) clearance?

Tablo Cartridge received FDA 510(k) clearance on 2021-11-26, under 510(k) number K210782.

Who is the listed applicant for Tablo Cartridge?

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

What is the FDA product code for Tablo Cartridge?

The FDA product code for Tablo Cartridge is FJK.

列明Outset Medical, 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。

K253412Tablo血液透析系统（PN-0008000，PN-0006000U）K232776Tablo® 血液透析系统；TabloCart™ 带预过滤抽屉 K233335Tablo® 血液透析系统 K223248Tablo® 血液透析系统 K211370Tablo血液透析系统 K200741Tablo血液透析系统

查看所有 9 个设备 →

官方来源

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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。