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FDA 510(k)

自动组织处理单元

K号: K172717 · 2018-05-25

申请人Bsl Co.
决定日期2018-05-25
产品代码MUU
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Automatic Tissue Processing Unit is the device name listed in this FDA 510(k) record. The listed applicant is Bsl Co.. It received FDA 510(k) clearance on 2018-05-25 under 510(k) number K172717. The device is classified under product code MUU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Automatic Tissue Processing Unit?

Automatic Tissue Processing Unit is a medical device that received FDA 510(k) clearance on 2018-05-25. The listed applicant is Bsl Co.. The 510(k) number is K172717.

When did Automatic Tissue Processing Unit receive FDA 510(k) clearance?

Automatic Tissue Processing Unit received FDA 510(k) clearance on 2018-05-25, under 510(k) number K172717.

Who is the listed applicant for Automatic Tissue Processing Unit?

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

What is the FDA product code for Automatic Tissue Processing Unit?

The FDA product code for Automatic Tissue Processing Unit is MUU.

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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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：MUU）

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。

K210528IntelliFat 一次性脂肪组织采集和转移套装，IntelliFat Body On Demand (BOD) 套件Millennium Medical Technologies Inc (Dba Cellmyx)K203800SyntrFuge SystemSyntr Health Technologies, Inc.K202443Smart Kit Basic, Smart Kit ProBsl Co., Ltd.K193539REVOLVE ENVI 600 高级脂肪系统Lifecell CorporationK193363Dermapose RefreshPuregraft, LLCK182732JTL-250-01Jointechlabs, Inc.

官方来源

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