ANNE 儿科
K号: K221530 · 2022-11-22
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申请人Sibel, Inc.
决定日期2022-11-22
产品代码DRG
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]
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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
ANNE Pediatric is the device name listed in this FDA 510(k) record. The listed applicant is Sibel, Inc.. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K221530. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ANNE Pediatric?
ANNE Pediatric is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Sibel, Inc.. The 510(k) number is K221530.
When did ANNE Pediatric receive FDA 510(k) clearance?
ANNE Pediatric received FDA 510(k) clearance on 2022-11-22, under 510(k) number K221530.
Who is the listed applicant for ANNE Pediatric?
The FDA 510(k) record lists Sibel, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ANNE Pediatric?
The FDA product code for ANNE Pediatric is DRG.
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Sibel, 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。
相关器械（代码：DRG）
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。
K261569UbiqVue™ 2AYe 心脏系统（UX2253）Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos 心肺康复The ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A 多参数系统（UX2550）Lifesignals, Inc.
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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