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FDA 510(k)

IntelliFat 一次性脂肪组织采集和转移套装，IntelliFat Body On Demand (BOD) 套件

K号: K210528 · 2022-03-16

申请人Millennium Medical Technologies Inc (Dba Cellmyx)
决定日期2022-03-16
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

IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit is the device name listed in this FDA 510(k) record. The listed applicant is Millennium Medical Technologies Inc (Dba Cellmyx). It received FDA 510(k) clearance on 2022-03-16 under 510(k) number K210528. 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 IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit?

IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit is a medical device that received FDA 510(k) clearance on 2022-03-16. The listed applicant is Millennium Medical Technologies Inc (Dba Cellmyx). The 510(k) number is K210528.

When did IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit receive FDA 510(k) clearance?

IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit received FDA 510(k) clearance on 2022-03-16, under 510(k) number K210528.

Who is the listed applicant for IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit?

The FDA 510(k) record lists Millennium Medical Technologies Inc (Dba Cellmyx) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit?

The FDA product code for IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit is MUU.

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。

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。

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.K191564Progenikine 浓缩系统 25 mL 系统Emcyte Corporation

官方来源

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