Bioflux 软件 II
K号: K201040 · 2020-07-29
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申请人Biotricity
决定日期2020-07-29
产品代码DSH
咨询委员会CV
请注意，由于原文未提供具体内容，以下是一个示例翻译：
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产品名称：[产品名称]
公司名称：[公司名称]
FDA批准号：[FDA批准号]
510(k)申请号：[510(k)申请号]
PMA申请号：[PMA申请号]
临床试验注册号：[NCT]
PubMed ID：[PMID]
产品标识符：[标识符]
产品URL：[URL]
---
请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定实质等同
器械摘要
Bioflux Software II is the device name listed in this FDA 510(k) record. The listed applicant is Biotricity. It received FDA 510(k) clearance on 2020-07-29 under 510(k) number K201040. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Bioflux Software II?
Bioflux Software II is a medical device that received FDA 510(k) clearance on 2020-07-29. The listed applicant is Biotricity. The 510(k) number is K201040.
When did Bioflux Software II receive FDA 510(k) clearance?
Bioflux Software II received FDA 510(k) clearance on 2020-07-29, under 510(k) number K201040.
Who is the listed applicant for Bioflux Software II?
The FDA 510(k) record lists Biotricity as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bioflux Software II?
The FDA product code for Bioflux Software II is DSH.
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Biotricity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。
相关器械（代码：DSH）
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。
K260157LifeLens生理监测仪LifeLens Technologies, Inc.K252389Rhythm Master 心电图贴片 (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK诊所（型号7100）Vitalograph , Ltd.K243650Zio®监护仪（DFG0001）iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch（ATP-C130/ATP-C70）Atsens Co., Ltd.
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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